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

Recall Z-0819-2013 — Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

U.S. FDA — Device Enforcement · United States · 2012-12-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0819-2013
Date of alert
2012-12-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Quidel Corporation
Product category
device
Product type
Devices
Reported risk: Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
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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