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.
- Product
- Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
- Category
- Medical Device
- Distribution
- Distributed nationwide