RegWardenFDA facility compliance records
Facility

INSTRUMENTATION LABORATORY CO.

24 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2013: 3 recalls; 2014: 2 recalls; 2015: 1 recalls; 2017: 1 recalls, 1 inspections; 2018: 1 recalls; 2019: 1 recalls; 2021: 2 recalls; 2022: 2 recalls; 2023: 3 recalls; 2024: 1 recalls; 2025: 3 recalls; 2026: 3 recalls1’123’132’141’15’162’171’181’19’202’212’223’231’243’253’26
  • Recalls (24)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

20263 records
  • Class IIOngoing2026-05-21
    The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalitie…
  • Class IIOngoing2026-05-08
    Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
  • Class IIOngoing2026-01-20
    Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requir…
20253 records
  • Class IIOngoing2025-12-11
    Potential for microbial contamination.
  • Class IIIOngoing2025-11-18
    Recalled lots were manufactured with double the amount of preservative concentration.
  • Class IIOngoing2025-02-03
    Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints,…
20241 record
  • Class IIOngoing2024-12-18
    Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
20233 records
  • Class IIOngoing2023-09-29
    Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to fa…
  • Class IIOngoing2023-07-13
    Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
  • Class IIOngoing2023-02-03
    Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
20222 records
  • Class IIOngoing2022-04-08
    Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
  • Class IIOngoing2022-02-22
    Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL…
20212 records
  • Class IIOngoing2021-10-13
    The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential ri…
  • Class IIOngoing2021-08-25
    Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
20191 record
20181 record
20171 record
  • Class IITerminated2017-08-02
    Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
20151 record
20142 records
  • Class IITerminated2014-11-21
    Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish c…
  • Class IITerminated2014-06-03
    Potential for sample misidentification.
20133 records
20121 record

FDA inspections (1)

  • VAI2017-04-19
    Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “INSTRUMENTATION LABORATORY CO. (FEI 2431530) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2431530-instrumentation-laboratory-co/

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