Inpeco recalls FlexLab X Potassium Test System due to unverified safety of blood test results. This may cause inaccurate patient results or delays in treatment.
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.
Inpec: The FlexLab X Potassium Test System has been recalled because its blood test function hasn't been safety-checked by the FDA. This could lead to incorrect test results or delayed patient care.
The system's blood test function for hemolysis, icterus, and lipemia (HIL) hasn't been evaluated by the FDA for safety and effectiveness. This could cause incorrect test results or delays in patient care.
Healthcare facilities using the FlexLab X Potassium Test System are likely affected. Patients receiving blood tests through this system may be at risk of inaccurate results.
Check for the FlexLab X (FXX) System with model number FLX-056-40 and serial number FXX.0015. The product was sold with UDI 07640172344002.
Verify the model number FLX-056-40 and serial number FXX.0015 to confirm if your system is affected.
The FlexLab X System's blood test function for hemolysis, icterus, and lipemia hasn't been evaluated by the FDA for safety and effectiveness, which could cause incorrect results or delays in patient care.
The recall record does not specify a remedy, so check product details to confirm if your system is affected.
The recall states the hazard could cause incorrect results or delays in patient care, but not serious injury. The danger level is low_risk.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-0107-2026 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-0107-2026 from Inpeco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
