FDA Device recall Z-2498-2021
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 by Roche Molecular Systems, citing customers have reported an increased number of false positive SARS-CoV-2 results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2498-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-04 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
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.
Identifiers
| code_info | Lot 10119Z |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2498-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.