FDA recall record · openFDA

Inpeco S.A.

10 FDA recalls on record (2023–2025) — 10 device. 10 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassi 5

Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processi 1

The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia 1

The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia ( 1

The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may resu 1

Recalls

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic Class II 2025-09-03 FlexLab (FLX) System. Potassium Test System. in vitro diagnostic Class II 2025-09-03 FlexLab (FLX); Version: FLX-217-40; Class II 2025-10-30 FlexLab (FLX); Version: FLX-217-10; Class II 2025-10-30 Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to au Class II 2023-11-03 Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accel Class II 2023-03-10 Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accele Class II 2023-03-10 Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Class II 2023-03-10 PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator Class II 2023-03-10 Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Acceler Class II 2023-03-10

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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