Randox Calibration Serum Level 3 Recalled for Bilirubin Bias
Randox Laboratories is recalling 98 kits of Calibration Serum Level 3 (CAL 3) due to a positive bias in bilirubin measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a measurement bias (up to +15%) in a calibrator, which is a significant quality issue but does not involve direct physical injury or a high-risk pathogen, fitting the Moderate criteria for low-risk contamination or labeling/quality errors.
Plain-English summary
Randox Laboratories Ltd. is recalling 98 kits of Calibration Serum Level 3 (CAL 3), catalogue number CAL2351, lot 1162UE. The product is a multi-analyte mixture calibrator used in laboratory testing.
The recall is due to a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges. Randox attributes this bias to bilirubin instability in the calibrator. The issue is evident in both Quality Control (QC) and Patient samples.
The affected product was distributed domestically in IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, and MS, as well as in numerous foreign countries. Users should stop using the affected lot and contact Randox Laboratories for instructions on return or replacement.
The recalled product
- Product
- Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 98
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch / Lot number: 1162UE GTIN: 05055273200966
Distribution
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