Class II — Inpeco S.A.
| Recalling firm | Inpeco SA |
|---|---|
| Registered facility | INPECO SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients. |
| Product | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System |
| Quantity | 18 |
| Distribution | Distributors in 2 states: NY and IL. |
| Initiated | 2018-02-13 |
| Classified | 2018-05-10 |
| Terminated | 2019-04-03 |
| Recall number | Z-1798-2018 |
| 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-1798-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79645/
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