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

Recall Z-1414-2021 — cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

U.S. FDA — Device Enforcement · United States · 2021-03-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1414-2021
Date of alert
2021-03-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Molecular Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07341920190
Reported risk: Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
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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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.