Recall Z-2498-2021— Roche Molecular Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2021-08-04, terminated 2024-02-23. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190. Reason: Customers have reported an increased number of false positive SARS-CoV-2 results..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-04
- Terminated
- 2024-02-23
- Firm location
- Branchburg, NJ, United States
Product description
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Reason for recall
Customers have reported an increased number of false positive SARS-CoV-2 results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.