FDA Device recall Z-2203-2016
cobas¿ Liat Influenza A/B Quality Control Kit
- FDA Device
- Class III
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class III recall of cobas¿ Liat Influenza A/B Quality Control Kit by Roche Molecular Systems, citing kit labeled with the incorrect expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2203-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-17 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Molecular Systems |
| Distribution | AK, HI, IA, LA, MA, MD, ME, MN, MT, NC, NY, OR, PA, TX, VA, WA |
Product
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
Reason
Kit labeled with the incorrect expiration date.
Identifiers
| code_info | Lot Numbers: 51222E, 60121H, 60201D, and 60229F |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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 LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Device · Class II · 2022-04-06 · Roche Molecular Systems
All Roche Molecular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2203-2016%22
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