Microalbumin Calibrator Series recall
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Why was Microalbumin Calibrator Series recalled?
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 05055273204544 (1) Batch/Lot: 602114 /1083MA-1087MA (2) Batch/Lot: 636645 /1108MA-1112MA (3) Batch/Lot: 662429 /1083MA- 1087MA
- Product
- Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of GA, MA, WV including PR.
- Recall date
- April 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)