Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Batch / Lot number: 1162UE GTIN: 05055273200966
Products Sold
Batch / Lot number: 1162UE GTIN: 05055273200966
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351 due to 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 1. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 03/29/2021, Randox issued an Urgent Medical Device Correction notice to customer via letter notifying them, Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator Calibration Serum Level 3. Action to be taken: -Discuss the contents of this notice with your Medical Director. -Complete and return the response form 12187-QA to technical.services@ randox.com within five working days. For questions or concerns contact Randox Technical Services.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, IL, IN, MD, MA, MN, MS, NE, NJ, NY, OR, TX, VA, DC, PR
Page updated: Jan 10, 2026