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 | The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result. |
| Product | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.) |
| Quantity | 262 total, 52 US |
| Distribution | Domestic distribution nationwide . Foreign distribution worldwide. |
| Initiated | 2021-09-10 |
| Classified | 2021-10-12 |
| Recall number | Z-0087-2022 |
| 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-0087-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88700/
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