cobas 5800 instrument — Class II medical device recall Z-0097-2023
Terminated recall by Roche Molecular Systems, Inc., reported 2022-10-26. Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead
| Recall number | Z-0097-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2022-09-08 |
| Classified | 2022-10-17 |
| Reported by FDA | 2022-10-26 |
| Terminated | 2024-11-07 |
| Countries outside the US | AE, AT, BE, CH, CL, CO, CZ, DE, ES, FR, GB, GR, HK, IE, IT, JM, JP, LT, NI, OM, PK, PL, PT, SE |
| Quantity | 179 ous |
| UPC / GTIN / UDI-DI | 07613336170076 |
Product
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Reason for recall
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0097-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.