United StatesInpeco’s FlexLab (FLX) System and FlexLab X (FXX) System Potassium Test Systems — including the Sample Integrity Module (SIM) that reports hemolysis, icterus, and lipemia (HIL) — are affected (PNs FLX-056-01, FLX-056-11, FLX-056-40; serials FLX.0204, .0205, .0209, .0210, .0216, .0220, .0221, .0222 and FXX.0015; 8 units and 1 unit distributed in CA and NY). The HIL function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or delays in patient results.
What's being recalled
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Recalling firm: Inpeco S.A., Lugano, Switzerland.
How to identify it
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. PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.
The hazard
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.
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to CA & NY.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)