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

Recall Z-2736-2024 — Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

U.S. FDA — Device Enforcement · Norway · 2024-06-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2736-2024
Date of alert
2024-06-17
Country / jurisdiction
Norway
Risk level
Class II
Risk type
recall
Brand
Abbott Diagnostics Technologies AS
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07070060014708
Reported risk: Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous 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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