Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic Recalled by Inpeco S.A. Due to The FlexLab X System Sample Integrity Module (SIM)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Inpeco S.A. directly.
Affected Products
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Quantity: 1 unit
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 2 states: CA, NY
About Inpeco S.A.
Inpeco S.A. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report