Inpeco S.A. recalls FlexLab
- Recalling company
- Inpeco S.A.
- Product
- FlexLab (FLX); Version: FLX-217-10;
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 30, 2025
- Reported
- Dec 3, 2025
- Distribution
- US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
- Status
- Ongoing
- Quantity
- 1 unit (OUS only)
- Lot / codes
- UDI-DI: 07640172340004 Serial number: FLX.0226;
- Company location
- Lugano, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0595-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0595-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.