cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Reported: April 21, 2021 Initiated: March 25, 2021 #Z-1414-2021
Product Description
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Reason for Recall
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
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- US: 5,430 units ; OUS 1528 units
- Distribution
- Nationwide WorldWide
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190. Recalled by Roche Molecular Systems, Inc.. Units affected: US: 5,430 units ; OUS 1528 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1414-2021.
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