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

Recall Z-0846-2014 — Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial vi

U.S. FDA — Device Enforcement · United States · 2014-01-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0846-2014
Date of alert: 2014-01-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Focus Diagnostics Inc
Product category: device
Product type: Devices

Reported risk: Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.

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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