Recall archive / FDA device enforcement
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic — FDA record Z-0107-2026
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 Sep 3, 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 X (FXX) System. Potassium Test System. in vitro diagnostic
- Reason
- The FlexLab X 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.
- Classification
- Class II
- Recalling firm
- Inpeco S.A.
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0107-2026
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 | PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to CA & NY.
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
- Oct 15, 2025
- Recall initiation date
- Sep 3, 2025
- Center classification date
- Oct 9, 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.