cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
Reported: April 21, 2021 Initiated: March 25, 2021 #Z-1413-2021
Product Description
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
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: 143,823 kits Ex-US: 57,219 kits
- Distribution
- Nationwide WorldWide
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190. Recalled by Roche Molecular Systems, Inc.. Units affected: US: 143,823 kits Ex-US: 57,219 kits.
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-1413-2021.
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