Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Recalled by Randox Laboratories Ltd. Due to Randox can confirm a positive bias for Total...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories Ltd. directly.
Affected Products
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Quantity: 98 kits
Why Was This 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.
Where Was This Sold?
This product was distributed to 15 states: CA, CT, IL, IN, MD, MA, MN, MS, NE, NJ, NY, OR, TX, VA, DC
About Randox Laboratories Ltd.
Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report