Microalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA recalls Microalbumin Calibrator Series due to negative measurement bias that may misclassify patient results. Laboratories using affected batches should review quality control data and consider recalibration.
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 involving calibration error in a clinical diagnostic product with potential for patient misclassification. No illnesses or injuries have been reported, but the measurement bias represents a real risk of harm in a healthcare setting.
Plain-English summary
The FDA has recalled Microalbumin Calibrator Series (Catalog Numbers MA1567 and MA2426), manufactured by Randox Laboratories Ltd. The product is used to calibrate microalbumin assays in clinical laboratories.
The recall was initiated because the calibrator runs with a negative bias compared to other methods. This bias may cause patient results to be misclassified. Users have reported potential shifts in quality control and patient sample recovery of up to 12%.
The affected product has been distributed nationwide in Georgia, Massachusetts, West Virginia, and Puerto Rico. Laboratories using the recalled batches (Lot 619282 / 1094MA-1098MA) should review their quality control data and take steps to ensure patient results have not been affected by the calibration inaccuracy.
Laboratory personnel should contact Randox Laboratories Ltd. for guidance on affected product lot numbers and appropriate corrective actions, including product replacement or recalibration procedures.
The recalled product
- Product
- Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- measurement-bias
- misclassification
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
Distribution
Distributed nationwide across the United States.
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