Microalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a calibration error that can cause patient result misclassification. While no illnesses or injuries have been reported, the potential for harm exists if miscalibrated results are used in clinical decision-making.
Plain-English summary
Randox Laboratories Ltd. is recalling the Microalbumin Calibrator Series (mALB CAL)-IVD, Catalog Number MA2426, which is used to calibrate microalbumin assay testing in clinical laboratories.
The recall is due to the calibrator running with a negative bias compared to other methods. This negative bias may cause misclassification of patient test results and affect Quality Control procedures by up to 12%.
The affected calibrators were distributed nationwide across Georgia, Massachusetts, West Virginia, and Puerto Rico. Affected batch/lot numbers are: 602114 (1083MA-1087MA), 636645 (1108MA-1112MA), and 662429 (1083MA-1087MA).
Due to the risk of result misclassification, laboratory personnel should discontinue use of affected calibrators and contact Randox Laboratories for guidance on appropriate replacement or alternative calibration methods.
The recalled product
- Product
- Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- calibration-error
- result-misclassification
Distribution
Distributed nationwide across the United States.
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