FDAFDA · Food and drugs·Recall number Z-1414-2021
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Published April 21, 2021 · Recall initiated: March 25, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Nationwide WorldWide
- Lot
- All serial ID numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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