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

Recall Z-0828-2022 — cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

U.S. FDA — Device Enforcement · United States · 2021-11-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0828-2022
Date of alert
2021-11-16
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)
07613336100097
Reported risk: Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.