Recall Z-0282-2020
Randox Laboratories Ltd. · initiated August 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0282-2020
- Initiated
- August 9, 2019
- Terminated
- January 8, 2021
- Product code
- DHR – System, Test, Rheumatoid Factor
- Quantity
- 17 kits
- Distribution
- US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0283-2020 Class II | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032…The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British… | 08/09/2019Terminated |