Randox Laboratories is recalling 14 units of the Microalbumin Calibrator Series (mALB CAL) because the calibrators are running with a negative bias. This defect can lead to incorrect patient test results and a shift in quality control checks of up to 12%. The recall affects two specific catalog numbers (MA1567 and MA2426) across multiple batches used in clinical laboratory settings. Consumers and healthcare providers should be aware that this issue could lead to the misclassification of patient samples during medical testing.
The calibrators provide inaccurate reference points for the Microalbumin Assay, causing the testing equipment to underestimate or overestimate albumin levels by up to 12%. This negative bias may cause healthcare providers to misinterpret patient results, potentially leading to incorrect medical diagnoses or inappropriate treatment plans.
Manufacturer instructions for device correction
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.
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Sources: FDA iRES · Raw API Response
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