Inpeco S.A. recalled eight units of its FlexLab (FLX) Potassium Test System on September 3, 2025. The system's Sample Integrity Module may produce erroneous results due to unverified functions. Healthcare providers must stop using the device immediately and follow the manufacturer's instructions.
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.
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 recalled products include the FlexLab (FLX) System with model numbers 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, and FLX.0222. These devices were distributed in California and New York. No pricing information is available.
The Sample Integrity Module in the FlexLab (FLX) System determines hemolysis, icterus, and lipemia in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, potentially leading to erroneous results or delays in patient results.
No specific incidents, injuries, or deaths have been reported related to this recall. The potential for erroneous results poses a high risk to patient safety.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Inpeco S.A. or consult your healthcare provider for further actions.
For more information, contact Inpeco S.A. via email. Visit the recall notification page for further details.
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