FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes.
What to do
FDA enforcement status: Terminated
Brands named
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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