Randox Rheumatoid Factor Standard Recalled for Value Adjustment
Randox Laboratories is recalling 17 Rheumatoid Factor Standard kits because assigned values over-recovered against reference material. The values have been adjusted to align with the reference standard.
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, but the source text describes a calibration adjustment to align values with reference material without reporting any illnesses, injuries, or adverse health consequences. This aligns with the rubric for moderate severity involving minor labeling or calibration errors without reported harm.
Plain-English summary
Randox Laboratories Ltd. is recalling 17 kits of the Rheumatoid Factor Standard (RF CAL), Catalogue Number RF2301. This in vitro diagnostic reagent is used for the quantitative determination of rheumatoid factors in human serum to facilitate the detection and diagnosis of Rheumatoid Arthritis.
The recall is due to the assigned value for Rheumatoid Factor over-recovering against the reference material, specifically the RF serum, 1st British standard from NIBSC (Ref = 64/002). The calibrator values have been adjusted to re-align to the reference material.
The affected products were distributed nationwide in the states of West Virginia, Maine, New Jersey, California, and Puerto Rico. The specific batch/lot numbers involved are 463479/1325-1329RF, 466715/1325-1329RF, 474059/1339-1343RF, and 480410/1347-1351RF. Users should check their inventory for these specific lot numbers and stop using the affected kits.
The recalled product
- Product
- Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human…
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 17
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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