Inpeco recalls FlexLab Potassium Test System due to untested safety of blood sample analysis function. This may cause inaccurate test results or delayed patient care. Affected units have specific serial numbers and part numbers.
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.
Inpeco is recalling its FlexLab Potassium Test System because a blood sample analysis feature hasn't been safety-tested by the FDA. This could lead to incorrect test results or delays in patient care. Affected units have specific serial numbers and part numbers.
The system's blood sample analysis feature (which checks for hemolysis, icterus, and lipemia) hasn't been evaluated for safety and effectiveness by the FDA. This could cause incorrect test results or delays in patient care.
Healthcare facilities using the FlexLab Potassium Test System with specific serial numbers are affected. Patients receiving tests from these systems may be at risk of inaccurate results.
Check for serial numbers FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, or FLX.0222 on the device. The product part numbers are FLX-056-01 or FLX-056-11.
Look for serial numbers FLX.0204 through FLX.0222 on the FlexLab system.
The FlexLab System's blood sample analysis feature hasn't been safety-tested by the FDA, which could cause incorrect test results or delays in patient care.
Check the serial numbers on your device. If it matches the listed numbers, contact Inpeco for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-0106-2026 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-0106-2026 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.
