Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0087-2022 — FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

U.S. FDA — Device Enforcement · Switzerland · 2021-09-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0087-2022
Date of alert
2021-09-10
Country / jurisdiction
Switzerland
Risk level
Class II
Risk type
recall
Brand
Inpeco S.A.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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