Randox Liquid Protein Calibrators Recalled for Rheumatoid Factor Value Adjustment
Randox Laboratories is recalling 100 kits of Liquid Protein Calibrators because the assigned value for Rheumatoid Factor over-recovered against the reference material. The calibrator values have been adjusted to re-align to the reference material.
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, but the source text describes a technical calibration adjustment to align with reference material rather than a contamination or defect causing direct physical harm. This aligns with the rubric for moderate severity involving minor labeling or calibration errors without reported injury.
Plain-English summary
Randox Laboratories Ltd. is recalling 100 kits of Liquid Protein Calibrators (SP CAL (LIQ)), Catalogue Number IT2691. The affected products are identified by Batch/Lot numbers 440973 /1748 1752IT, 451414 /1748 1752IT, 470531 /1813 1817IT, and 480859 /1813 1817IT. These products were distributed nationwide in the United States, specifically in the states of West Virginia, Maine, New Jersey, and California, as well as in Puerto Rico.
The recall was initiated because the assigned value for Rheumatoid Factor over-recovered against the reference material RF serum, 1st British standard from NIBSC (Ref = 64/002). The calibrator values have been adjusted to re-align to the reference material. These calibrators are intended for in vitro diagnostic use in the calibration of various assays on Clinical Chemistry and Immunoassay systems.
The source text does not specify instructions for consumers or healthcare providers regarding the return or disposal of the recalled product.
The recalled product
- Product
- Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealb
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 100
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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