Rheumatoid Factor Standard recall
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced…
Why was Rheumatoid Factor Standard recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF
- Product
- Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 17 kits
- Distribution
- US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.
- Recall date
- November 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)