RegWardenFDA facility compliance records
Facility

ABBOTT IRELAND DIAGNOSTICS DIVISION

68 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 4 recalls; 2013: 1 recalls; 2014: 4 recalls; 2015: 4 recalls; 2016: 3 recalls; 2017: 4 recalls; 2018: 8 recalls; 2019: 8 recalls; 2020: 4 recalls; 2021: 8 recalls; 2022: 8 recalls; 2023: 5 recalls; 2024: 2 recalls; 2025: 5 recalls4’121’134’144’153’164’178’188’194’208’218’225’232’245’25’26
  • Recalls (68)

Devices registered here (2)

  • Single (Specified) Analyte Controls (Assayed And Unassayed)
    Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660
  • Calibrator, Secondary
    Product code JIT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1150

Recalls & enforcement

20255 records
  • Class IIOngoing2025-11-13
    Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to er…
  • Class IIOngoing2025-09-18
    Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
  • Class IOngoing2025-09-10
    Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
  • Class IIOngoing2025-03-18
    When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
  • Class IIOngoing2025-03-17
    Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
20242 records
  • Class IIOngoing2024-06-14
    1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hema…
  • Class IIOngoing2024-02-21
    The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
20235 records
  • Class IIOngoing2023-10-19
    The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
  • Class IIOngoing2023-10-19
    The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
  • Class IIOngoing2023-09-28
    Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
  • Class IOngoing2023-06-12
    There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
  • Class IIOngoing2023-05-30
    There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new…
20228 records
  • Class IIIOngoing2022-11-24
    Reaction vessels may contain a potential contaminant that could affect their optical performance.
  • Class IIOngoing2022-07-26
    One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
  • Class IIOngoing2022-06-09
    There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
  • Class IITerminated2022-06-09
    When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
  • Class IITerminated2022-04-28
    Incorrect product labeling.
  • Class IITerminated2022-03-24
    Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
  • Class IIOngoing2022-03-08
    This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
  • Class IIOngoing2022-02-03
    Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
20218 records
  • Class IITerminated2021-11-16
    As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
  • Class IITerminated2021-11-09
    Instructions for use were updated.
  • Class IIOngoing2021-09-29
    Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optic…
  • Class IIOngoing2021-07-26
    Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of…
  • Class IIOngoing2021-07-12
    A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
  • Class IIOngoing2021-06-10
    There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead t…
  • Class IITerminated2021-05-05
    Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
  • Class IITerminated2021-04-22
    Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.
20204 records
  • Class IITerminated2020-05-22
    High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
  • Class IITerminated2020-04-02
    In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results.
  • Class IIITerminated2020-04-01
    Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
  • Class IITerminated2020-02-28
    Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
20198 records
  • Class IIITerminated2019-05-24
    Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
  • Class IITerminated2019-05-22
    Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with …
  • Class IITerminated2019-05-09
    The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
  • Class IITerminated2019-05-01
    Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.
  • Class IIITerminated2019-04-09
    Devices were delivered without the required dry ice.
  • Class IITerminated2019-04-05
    In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.
  • Class IITerminated2019-02-20
    There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
  • Class IITerminated2019-01-02
    Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of…
20188 records
  • Class IITerminated2018-11-19
    The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
  • Class IITerminated2018-09-07
    The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules…
  • Class IITerminated2018-08-28
    There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
  • Class IITerminated2018-07-18
    The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
  • Class IITerminated2018-07-17
    There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
  • Class IITerminated2018-06-14
    Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exc…
  • Class IITerminated2018-05-16
    An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
  • Class ITerminated2018-04-05
    Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
20174 records
  • Class IITerminated2017-12-08
    There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
  • Class IICompleted2017-09-29
    The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
  • Class IITerminated2017-04-18
    Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHIT…
  • Class IITerminated2017-02-13
    The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
20163 records
  • Class IITerminated2016-10-11
    Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
  • Class IITerminated2016-03-24
    Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
  • Class IITerminated2016-03-24
    Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
20154 records
20144 records
  • Class IITerminated2014-07-22
    ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
  • Class IITerminated2014-04-30
    HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control …
  • Class IITerminated2014-04-07
    Package inserts have incorrect SmartWash parameters for Triglyceride.
  • Class IITerminated2014-02-12
    Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator an…
20131 record
  • Class IITerminated2013-08-12
    Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
20124 records
  • Class IITerminated2012-12-18
    Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers …
  • Class IITerminated2012-12-12
    The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
  • Class IITerminated2012-11-16
    Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs u…
  • Class IITerminated2012-05-30
    The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ABBOTT IRELAND DIAGNOSTICS DIVISION (FEI 3005094123) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005094123-abbott-ireland-diagnostics-division/

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