Reported May 19, 2021 · Terminated
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue 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
Is this the product you have?
- Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator
- Catalogue NumberCAL2351
- Lot codes and dates
- Batch / Lot number1162UE
- GTIN05055273200966
- Amount recalled
- 98 kits
Where it was sold
Why it was recalled
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.
This product could cause temporary or reversible health problems — stop using it.
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