Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is recalling Calibration Serum Level 3 (CAL 3), catalogue number CAL2351, lot 1162UE, a multi-analyte mixture calibrator used in laboratory testing. The product has a positive bias for Total Bilirubin and Direct Bilirubin measurements of up to 15% across the assay ranges. This positive bias, caused by bilirubin instability in the calibrator, affects both Quality Control and Patient samples. A total of 98 kits with lot number 1162UE were distributed domestically across multiple U.S. states and internationally to countries including Canada, Australia, France, Germany, and many others.
The recall record does not specify a remedy or recommended action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany, Greece, Hong Kong, Iraq, Italy, Ireland, Jordan, Kazakhstan, Kenya, Lithuania, Luxembourg, Mauritius, Mexico, Myanmar, Nepal, New Zealand, Pakistan, Palestine, Pol Quantity: 98 kits Lot/code info: Batch / Lot number: 1162UE GTIN: 05055273200966
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.