RegWardenFDA facility compliance records
Facility

INPECO SA

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

Activity by year

FDA actions on record by year2016: 1 recalls; 2018: 2 recalls; 2020: 7 recalls; 2021: 1 recalls; 2023: 2 recalls; 2025: 2 recalls12016201722018201972020120212022220232024220252026
  • Recalls (15)

Devices registered here (5)

  • Electrode, Ion-Specific, Chloride
    Product code CGZ (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1170
  • Calculator/Data Processing Module, For Clinical Use
    Product code JQP (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2100
  • Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
    Product code JJE (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2160
  • Electrode, Ion Specific, Sodium
    Product code JGS (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1665
  • Electrode, Ion Specific, Potassium
    Product code CEM (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1600

Recalls & enforcement

20252 records
  • Class IIOngoing2025-10-30
    The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedu…
  • Class IIOngoing2025-09-03
    The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or …
20232 records
  • Class IIOngoing2023-11-03
    Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
  • Class IIOngoing2023-03-10
    Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat …
20211 record
  • Class IIOngoing2021-09-10
    The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
20207 records
  • Class IITerminated2020-08-07
    Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
  • Class IITerminated2020-07-14
    When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to…
  • Class IIOngoing2020-04-07
    The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
  • Class IITerminated2020-04-07
    The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line af…
  • Class IITerminated2020-04-07
    When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
  • Class IIOngoing2020-04-07
    In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Det…
  • Class IITerminated2020-04-07
    The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
20182 records
  • Class IITerminated2018-08-24
    The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a …
  • Class IITerminated2018-02-13
    Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
20161 record
  • Class IITerminated2016-10-04
    Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.

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. “INPECO SA (FEI 3010825766) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010825766-inpeco-sa/

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