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

Recall Z-1349-2023 — Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

U.S. FDA — Device Enforcement · United States · 2022-11-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1349-2023
Date of alert
2022-11-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Molecular, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884999048034
Reported risk: The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
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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