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Inpeco S.A. recalls FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Recalled October 20, 2021 · FDA recall Z-0087-2022 · Inpeco S.A
Hazard
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result. · FDA Class II
Units
262 total, 52 US
Sold at
Domestic distribution nationwide . Foreign distribution worldwide.
Description
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
Product
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Manufacturer(s)
Inpeco S.A.
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →