FDAHealthSeptember 3, 2025
Inpeco S.A. — FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
⚠️ 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.
Is this relevant to me?
- Geography
- US, CA, NY
- Source agency
- FDA
- Category
- Health
- Published
- September 3, 2025
US distribution to CA & NY.
What's affected?
- Product
- FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
- Brand
- Inpeco S.A.
- Lot code
- PN: FLX-056-01, FLX-056-11; UDI: 07640172340004: Serial No. FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222.
Additional details
PN: FLX-056-01, FLX-056-11; UDI: 07640172340004: Serial No. FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8 units.
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