Inpeco recalled eight FlexLab FLX System Potassium Test System units sold in California and New York. The recall targets the Sample Integrity Module HIL function, which detects hemolysis, icterus and lipemia. The FDA has not evaluated this function for safety or effectiveness, risking erroneous results or delays. Labs should stop using the device immediately.
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 FlexLab System is a laboratory instrument used for clinical chemistry testing. The Potassium Test System is part of this platform. The Sample Integrity Module verifies sample quality indicators such as HIL. This recall concerns the HIL function within SIM.
The SIM HIL function has not been evaluated by the FDA for safety and effectiveness. Using it may lead to incorrect results or delays in reporting patient results.
This recall is not described as part of a broader industry pattern in the provided information.
Healthcare labs may experience data integrity issues or result delays if HIL data is unreliable, potentially affecting patient care and workflow.
Identifiers are on device labels, packaging, and the associated documentation provided with the unit.
There is no public timeline provided in the recall for refunds or replacements. Expect manufacturer guidance via recall notice updates.
Keep a copy of the recall notice, inventory lists, serial numbers, dates of purchase, internal communications, and any correspondence with the manufacturer.
Model numbers: FLX-056-01, FLX-056-11, FLX-0204, FLX-0205, FLX-0209, FLX-0210, FLX-0216, FLX-0220, FLX-0221, FLX-0222. Sold in the United States with distribution to California and New York. Quantity: 8 units. Brand: Inpeco. Status: Active recall. SoldFrom: Unknown. SoldTo: CA, NY. Price: Unknown.
No injuries or incidents have been reported.
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