BioPlex 2200 recall
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Why was BioPlex 2200 recalled?
Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Lot # 301481; UDI GTIN: 00847865000857
- Product
- BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Quantity
- 1544 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
- Recall date
- April 19, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)