Class II — Inpeco S.A.
| Recalling firm | Inpeco SA |
|---|---|
| Registered facility | INPECO SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing. |
| 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 |
| Quantity | 1 unit US: 14 units OUS |
| Distribution | Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN. |
| Initiated | 2023-11-03 |
| Classified | 2023-12-15 |
| Recall number | Z-0560-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Inpeco S.A. (Z-0560-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93423/
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