FDA Enforcement
Class II
Ongoing
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
Recall: Z-1413-2021
·
Reported April 21, 2021
Enforcement
- Recall Number
- Z-1413-2021
- Event ID
- 87622
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Roche Molecular Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 21, 2021
- Initiation Date
- March 25, 2021
- Classification Date
- April 12, 2021
- Address
- 1080 US Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States
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
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
Code Info
All lot numbers
Distribution
Nationwide WorldWide
Quantity
US: 143,823 kits Ex-US: 57,219 kits