Liquid Protein Calibrators recalled for reference material realignment correction
Randox Laboratories is recalling 1,764 units of Liquid Protein Calibrators used in immunoassays due to realignment of C3 and Haptoglobin to the correct reference material standard. Distribution was limited to seven U.S. states.
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: FDA Class II designation. This is a voluntary realignment recall to correct calibrator reference standards with no reported illnesses or injuries. The firm is proactively correcting calibrators to ensure proper traceability to international standards.
Plain-English summary
Randox Laboratories Ltd. is recalling 1,764 units of Liquid Protein Calibrators (catalog IT2691) used with IgA, IgG, and IgM immunoassays. The recall involves C3 and Haptoglobin liquid protein calibrators that require realignment to reference material ERM-DA470k/IFCC.
The firm has determined that these calibrators need to be realigned to the proper reference standard to ensure accurate calibration of diagnostic assays.
The affected products were distributed domestically to clinical laboratories in California, Florida, Illinois, Maine, New Jersey, Ohio, and Oregon. Specific lot numbers with expiration dates are available in the FDA recall notice.
Laboratories that have received affected calibrators should refer to Randox Laboratories or the FDA for guidance on product handling and replacement instructions.
The recalled product
- Product
- Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 1,764
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 (8)
- Catalog No. IT2691
- GTIN 05055273204032
- Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25)
- 647342/2154IT-2158IT (03/28/25)
- 634886/2112IT-2116IT (07/28/24)
- 634887/2112IT-2116IT (07/28/24)
- 627224/2112IT-2116IT (07/28/24)
- 627222/2112IT-2116IT (07/28/24)
Distribution
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