Reported Apr 24, 2024 · Ongoing
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North) · N/A
Is this the product you have?
- Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate
- the Microalbumin Assay Catalog NumberMA2426
- Lot codes and dates
- GTIN05055273204544 (1)
- Batch/Lot602114 /1083MA-1087MA (2)
- Batch/Lot636645 /1108MA-1112MA (3)
- Batch/Lot662429 /1083MA- 1087MA
- Amount recalled
- 6 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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%.
This product could cause temporary or reversible health problems — stop using it.
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