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.
What this means for you
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
Related recalls
Same manufacturer · Randox Laboratories Ltd.
See all →- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- ModerateEvidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
FDA (Devices) · 2024-05-15
- HighMicroalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
Same hazard · measurement bias
See all →- HighEmano Flow Uroflowmetry App Recalled Over Biased Flow Estimates
FDA (Devices) · 2026-07-29
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighCapillary tubes recalled over a positive bias in potassium results
FDA (Devices) · 2026-02-25
- HighVITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
FDA (Devices) · 2024-12-04
- Highepoc BGEM BUN Test Cards recalled for sodium measurement bias
FDA (Devices) · 2024-11-13