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

Recall Z-2095-2015 — Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discriminatio

U.S. FDA — Device Enforcement · United States · 2015-06-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2095-2015
Date of alert: 2015-06-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alere Scarborough, Inc. dba Binax, Inc.
Product category: device
Product type: Devices

Reported risk: Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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