Inpeco S.A. recalled one unit of the FlexLab X (FXX) System on September 3, 2025. The recall affects the Sample Integrity Module, which has not been FDA evaluated for safety. This may cause erroneous results or delays in patient testing.
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
The recalled product is the FlexLab X (FXX) System, Model PN: FLX-056-40 and UDI: 07640172344002, Serial No. FXX.0015. It was distributed in California and New York.
The Sample Integrity Module (SIM) of the FlexLab X System determines hemolysis, icterus, and lipemia in blood samples. The FDA has not evaluated this function for safety and effectiveness, potentially leading to erroneous test results.
No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to the potential for erroneous results.
Stop using the FlexLab X System immediately. Follow the recall instructions provided by Inpeco S.A. and contact your healthcare provider for guidance.
For further assistance, contact Inpeco S.A. via email. Visit the recall notice at the FDA website for more information.
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