Inpeco S.A.

Complete recall history across all FDA and CPSC categories — 33 total recalls

Inpeco S.A. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (33)

FDA medical device enforcement actions by Inpeco S.A.

Date Product Reason Class
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-10; The Aliquoter Module (mALX) may generate secondary sample tubes without label... Class II
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-40; The Aliquoter Module (mALX) may generate secondary sample tubes without labe... Class II
Sep 3, 2025 FlexLab (FLX) System. Potassium Test System. in vitro diagnostic The FlexLab System Sample Integrity Module (SIM) includes function that deter... Class II
Sep 3, 2025 FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic The FlexLab X System Sample Integrity Module (SIM) includes function that det... Class II
Nov 3, 2023 Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automat... Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM)... Class II
Mar 10, 2023 Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names ... Firmware versions have the potential to mis-associate sample IDs leading to i... Class II
Mar 10, 2023 PVT Interface Module (PVT)-Laboratory Automation system Brand names of the... Firmware versions have the potential to mis-associate sample IDs leading to i... Class II
Mar 10, 2023 Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand... Firmware versions have the potential to mis-associate sample IDs leading to i... Class II
Mar 10, 2023 Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names... Firmware versions have the potential to mis-associate sample IDs leading to i... Class II
Mar 10, 2023 Storage and Retrieval Module (SRM)-Laboratory Automation system Brand name... Firmware versions have the potential to mis-associate sample IDs leading to i... Class II
Sep 10, 2021 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different br... The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur ... Class II
Aug 7, 2020 FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-... Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track... Class II
Aug 7, 2020 Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual r... Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track... Class II
Aug 7, 2020 Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual r... Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track... Class II
Jul 14, 2020 FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212... When a Clot Detection Error is generated during the sample aspiration from th... Class II
Jul 14, 2020 Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) Th... When a Clot Detection Error is generated during the sample aspiration from th... Class II
Jul 14, 2020 Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX... When a Clot Detection Error is generated during the sample aspiration from th... Class II
Apr 7, 2020 Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-2... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads ... Class II
Apr 7, 2020 Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, F... The identified problem is an erroneous association between the carrier and th... Class II
Apr 7, 2020 Accelerator a3600 Automation System used with the following Modules: High Vol... The sensors which activate the safety switches may be affected by delayed act... Class II
Apr 7, 2020 FlexLab Automation System used with the following Modules: High Volume Storag... The sensors which activate the safety switches may be affected by delayed act... Class II
Apr 7, 2020 Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Pa... When analyzer sample carousel lid remains open or manual process is too long,... Class II
Apr 7, 2020 FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The... Potential for discrepant patient results due to a potential for the primary s... Class II
Apr 7, 2020 Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Pro... In certain firmware versions, in case a Clot Detection error (error code E0E0... Class II
Apr 7, 2020 FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00,... The identified problem is an erroneous association between the carrier and th... Class II
Apr 7, 2020 Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads ... Class II
Apr 7, 2020 Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FL... In certain firmware versions, in case a Clot Detection error (error code E0E0... Class II
Apr 7, 2020 Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N F... The identified problem is an erroneous association between the carrier and th... Class II
Apr 7, 2020 Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers... When analyzer sample carousel lid remains open or manual process is too long,... Class II
Apr 7, 2020 Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA ... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads ... Class II
Aug 24, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product... The firm has identified customer sites where there are modules on which the s... Class II
Feb 13, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Au... Module may freeze without generating user warning. There is a potential risk ... Class II
Oct 4, 2016 FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed ... Inpeco received several notifications from the field about burnt schuko socke... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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