FlexLab — Class II medical device recall Z-0596-2026
Ongoing recall by Inpeco S.A., reported 2025-12-03. The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which
| Recall number | Z-0596-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, N/A, Switzerland |
| Recall initiated | 2025-10-30 |
| Classified | 2025-11-25 |
| Reported by FDA | 2025-12-03 |
| Countries outside the US | AU, DE, ES, FI, FR, GB, IT, PT |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07640172344002 |
| Serial numbers | FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046 |
Product
FlexLab (FLX); Version: FLX-217-40;
Reason for recall
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes
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-0596-2026. 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.