FlexLab — Class II medical device recall Z-0087-2022
Ongoing recall by Inpeco S.A., reported 2021-10-20, distributed nationwide. The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect a
| Recall number | Z-0087-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, N/A, Switzerland |
| Recall initiated | 2021-09-10 |
| Classified | 2021-10-12 |
| Reported by FDA | 2021-10-20 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | ACP.334, AP2.0002, AP2.0003, AP2.0004, AP2.0005, AP2.0006, AP2.0007, AP2.0008, AP2.0010, AP2.0011, AP2.0012, AP2.0014, AP2.0015, AP2.0016, AP2.0017, AP2.0018, AP2.0019, AP2.0022, AP2.0023, AP2.0024, AP2.0025, AP2.0026, AP2.0027, AP2.0028, AP2.0029 and 237 more |
| Model numbers | FLX-021-00 |
Product
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Reason for recall
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.
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-0087-2022. 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.