Recall Z-0282-2020 ยท DHR System, Test, Rheumatoid Factor
Randox Laboratories Ltd.
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 observ
| Date | Aug 9, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 teclhnical.services@randox.com within five working days. |
| Quantity | 17 kits |
| Distribution | US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972220 | RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT Randox Laboratories, Ltd., Sep 9, 1997 |