Inpeco recalls
6 official recalls and safety alerts involving Inpeco since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Inpeco or the relevant agency.
- 2025-12-03
USInpeco S.A. recalls FlexLab (FLX); Version: FLX-217-40;
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…
FDA · DeviceInpeco S.A.US Domestic: MI. OUS International: Australia, Finland, France, Germany,…Official notice →- 2025-10-15
- US
Inpeco S.A. recalls FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
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…
- US
Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The FlexLab 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…
- 2023-12-27
- US
Inpeco S.A. recalls Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate…
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
FDA · DeviceInpeco S.A.Worldwide - US Nationwide distribution in the state of MA and the countries of…Official notice → - 2023-05-10
- US
Inpeco S.A. recalls Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP),…
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…
FDA · DeviceInpeco S.A.Worldwide distribution - US Nationwide and the countries of ARGENTINA,…Official notice → - 2021-10-20
- US
Inpeco S.A. recalls FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
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…
FDA · DeviceInpeco S.A.Domestic distribution nationwide . Foreign distribution worldwide.Official notice →