FDA Device recall Z-1414-2021
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
- FDA Device
- Class II
- ongoing
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190 by Roche Molecular Systems, citing 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 authori….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1414-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-25 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
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
Identifiers
| code_info | All serial ID numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1414-2021%22
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