FlexLab — Class II medical device recall Z-0106-2026
Ongoing recall by Inpeco S.A., reported 2025-10-15, distributed in CA, NY. The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and
| Recall number | Z-0106-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, Switzerland |
| Recall initiated | 2025-09-03 |
| Classified | 2025-10-09 |
| Reported by FDA | 2025-10-15 |
| Distributed | CA, NY |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 07640172340004 |
| Serial numbers | FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222 |
Product
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Reason for recall
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
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-0106-2026. 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.