Reported Jan 24, 2024 · Ongoing
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
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 · N/A
Is this the product you have?
- Calibration Serum Level 3 - IVD For use as a Calibrator in clinical
- chemistry assays Catalog NumberCAL2351
- Lot codes and dates
- GTIN05055273200966
- Lot/Batch No1214UE Exp
- Date28 Nov 2023
- Amount recalled
- 108 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
This product could cause temporary or reversible health problems — stop using it.
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