Recall archive / FDA device enforcement
FlexLab (FLX); Version: FLX-217-10; — FDA record Z-0595-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Inpeco S.A.
- Quantity
- 1 unit (OUS only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0595-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 07640172340004 Serial number: FLX.0226; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 3, 2025
- Recall initiation date
- Oct 30, 2025
- Center classification date
- Nov 25, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.