The FlexLab X System Potassium Test System was recalled by Inpeco S.A. on 2025-09-03 after the FDA identified an unvalidated hemolysis, icterus, and lipemia function in its Sample Integrity Module. The recall affects US distribution to California and New York. Stop using immediately and follow manufacturer instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Inpeco S.A. or your healthcare provider for instructions. Notification method: E-Mail
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The FlexLab X System is a clinical chemistry analyzer used in labs for potassium testing. It includes a Sample Integrity Module for evaluating sample quality.
The HIL function was not FDA evaluated for safety/effectiveness, risking incorrect results or delays.
This recall is not listed as part of a broader industry pattern in the data provided.
Potential for inaccurate potassium readings or delays in patient care, necessitating immediate cessation of use.
Refer to FDA recall page and manufacturer instructions for remediation
Refund or replacement timing not specified in data; follow manufacturer communications
Store recall notices and email communications; record lot numbers and serials for future reference
Model: FLX-056-40. UDI: 07640172344002. Serial No. FXX.0015. Distribution: US to CA & NY. Quantity: 1 unit. Seller/Manufacturer: Inpeco S.A.
No incidents or injuries are reported in the provided data.
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