Roche Cobas 8000 and Cobas PRO Interface Module — Class II medical device recall Z-0560-2024
Ongoing recall by Inpeco S.A., reported 2023-12-27, distributed nationwide. Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tub
| Recall number | Z-0560-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, N/A, Switzerland |
| Recall initiated | 2023-11-03 |
| Classified | 2023-12-15 |
| Reported by FDA | 2023-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, DK, ES, IT, NO |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07640172340004 |
| Serial numbers | FLX.0116, FLX.012, FLX.0121, FLX.0127, FLX.0128, FLX.0132, FLX.0150, FLX.0154, FLX.0165, FLX.0178, FLX.0208, FLX.031, FLX.048, FLX.049, FLX.067 |
Product
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0
Reason for recall
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
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-0560-2024. 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.