Official recall record
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-09-03
- Country of alert
- Switzerland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 07640172344002
- Brand on record
- Inpeco S.A.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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