Date Initiated by Firm |
August 09, 2019 |
Create Date |
November 04, 2019 |
Recall Status1 |
Terminated 3 on January 08, 2021 |
Recall Number |
Z-0282-2020 |
Recall Event ID |
83791 |
510(K)Number |
K972220
|
Product Classification |
System, test, rheumatoid factor - Product Code DHR
|
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 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. |
Code Information |
Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
17 kits |
Distribution |
US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DHR and Original Applicant = RANDOX LABORATORIES, LTD.
|