Reported Oct 15, 2025 · Ongoing
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Inpeco S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inpeco S.A. · Via San Gottardo 10 · Lugano · N/A
Is this the product you have?
- FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
- Lot codes and dates
- PN
FLX-056-01FLX-056-11
- UDI
07640172340004: Serial No. FLX.0204FLX.0205FLX.0209FLX.0210FLX.0216FLX.0220FLX.0221FLX.0222
- PN
- Amount recalled
- 8 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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