medical Class II Updated 2021-05-19

Randox Laboratories Ltd. recalls Calibration Serum Level 3 (CAL 3) - multi-analyte mixture ca

Recalled Product

Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351

Hazard / Issue

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.

Issued by

FDA

Affected States: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS
Lot/Code Info: Batch / Lot number: 1162UE GTIN: 05055273200966
View official government recall

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