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 serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.
FDA Recall Z-0282-2020 · Posted None
Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeDHR
Date Initiated2019-08-09
Date Terminated2021-01-08
Product Quantity17 kits
Reason for Recall
The assigned value for Rheumatoid Factor over recovers 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.
Firm Action
1. Review your reagent inventory and replace the value sheet with the new values provided.
2. Review results generated with the affected batches in line with the clinical profile of the patient.
3. Discuss the contents of this notice with your Medical Director.
4. Complete and return the response form 12187-QA to [email protected] within five working days.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.