Inpeco S.A. is recalling the FlexLab (FLX) and FlexLab X (FXX) Potassium Test Systems because the Sample Integrity Module (SIM) function has not been evaluated for safety and effectiveness by the FDA. This recall affects 9 units in total. Use of this unapproved function to check blood samples for quality issues like hemolysis, icterus, and lipemia may result in incorrect laboratory findings or delays in reporting patient test results. Laboratory supervisors should stop using this module and contact the manufacturer for further instructions.
Because the sample checking function was not cleared by the FDA, it may produce erroneous results regarding the quality of blood samples. If a laboratory relies on these results, they might report inaccurate medical data to doctors or experience delays in reporting, which could lead to improper patient care or treatment decisions.
Recall #: Z-0106-2026
Recall #: Z-0107-2026
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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