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Randox Laboratories Ltd. recalls Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Recalled May 19, 2021 · FDA recall Z-1563-2021 · Randox Laboratories
Hazard
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. · FDA Class II
Units
98 kits
Sold at
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Description
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.
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →