FDA Device recall Z-0828-2022
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
- FDA Device
- Class II
- ongoing
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 by Roche Molecular Systems, citing roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-16 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Reason
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
Identifiers
| code_info | UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Roche Molecular Systems
- cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas 5800 instrument, Material No. 08707464001
FDA Device · Class II · 2022-10-26 · Roche Molecular Systems - cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
FDA Device · Class II · 2021-10-20 · Roche Molecular Systems
All Roche Molecular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2022%22
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