FDAApril 7, 2020device
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing i...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
What to do
FDA enforcement status: Terminated
Brands named
inpeco
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAFlexLab (FLX); Version: FLX-217-10;2025-10-30
- FDAFlexLab (FLX); Version: FLX-217-40;2025-10-30
- FDAFlexLab (FLX) System. Potassium Test System. in vitro diagnostic2025-09-03
- FDAFlexLab X (FXX) System. Potassium Test System. in vitro diagnostic2025-09-03
- FDARoche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: ...2023-11-03
- FDAPVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A2023-03-10
- FDAInput Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-112023-03-10
- FDAVesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A2023-03-10
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