FDA Device recall Z-0097-2023
cobas 5800 instrument, Material No. 08707464001
- FDA Device
- Class II
- terminated
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of cobas 5800 instrument, Material No. 08707464001 by Roche Molecular Systems, citing reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0097-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-08 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Molecular Systems |
| Distribution | n/a |
Product
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Reason
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Identifiers
| code_info | Device Identifier: 07613336170076 All serial IDs are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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 LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Device · Class II · 2022-04-06 · 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-0097-2023%22
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