FDA Device recall Z-1195-2018
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic by Roche Molecular Systems, citing the cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the coloni….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1195-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-27 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Molecular Systems |
| Distribution | n/a |
Product
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Reason
The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
Identifiers
| code_info | Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users). |
|---|
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-1195-2018%22
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