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Inpeco S.A. FDA Recalls

11 recalls on file across devices, 0 of them Class I and 11 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
FlexLab (FLX); Version: FLX-217-40;Class IIOct 30, 2025The Aliquoter Module (mALX) may generate secondary sample t
FlexLab (FLX); Version: FLX-217-10;Class IIOct 30, 2025The Aliquoter Module (mALX) may generate secondary sample tu
FlexLab X (FXX) System. Potassium Test System. in vitro diagnosticClass IISep 3, 2025The FlexLab X System Sample Integrity Module (SIM) includes
FlexLab (FLX) System. Potassium Test System. in vitro diagnosticClass IISep 3, 2025The FlexLab System Sample Integrity Module (SIM) includes fu
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to auClass IINov 3, 2023Firmware of the Interface Module with Roche Cobas 8000 and C
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), AccelerClass IIMar 10, 2023Firmware versions have the potential to mis-associate sample
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator Class IIMar 10, 2023Firmware versions have the potential to mis-associate sample
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), AcceleClass IIMar 10, 2023Firmware versions have the potential to mis-associate sample
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Class IIMar 10, 2023Firmware versions have the potential to mis-associate sample
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), AccelClass IIMar 10, 2023Firmware versions have the potential to mis-associate sample
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)Class IISep 10, 2021The Firmware (FW) of the Automation System Interface Module

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