Z-1414-2021 Class II Ongoing
FDA device recall Z-1414-2021 was initiated by Roche Molecular Systems, Inc. on March 25, 2021 and is designated Class II. 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 L… The recall status is ongoing. Affected quantity: US: 5,430 units ; OUS 1528 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 5,430 units ; OUS 1528 units
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
Distribution Pattern
Nationwide WorldWide
Code Information
All serial ID numbers