Bio-Rad recalls Anti-CCP Reagent Pack Lot 301481 due to lower specificity (94.5% vs 97.8% in instructions) potentially causing false positives in tests.
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.
Bio-Rad is recalling a specific lot of Anti-CCP Reagent Packs because the test results may be less accurate than stated, increasing false positives. This could lead to incorrect health conclusions for users.
The recalled lot has a specificity of 94.5% (95% CI 91.8-96.4) instead of the 97.8% (95% CI 96.1-98.8%) stated in the instructions. This means the test may incorrectly flag healthy people as having the condition.
Users of the BioPlex 2200 Anti-CCP Reagent Pack with Lot # 301481 are affected. People using this test kit for medical diagnostics are most at risk of incorrect results.
Check for the lot number 301481 on the BioPlex 2200 Anti-CCP Reagent Pack (REF 665-3250). The product is sold as an IVD (in vitro diagnostic) kit.
Look for lot number 301481 on the BioPlex 2200 Anti-CCP Reagent Pack (REF 665-3250).
Bio-Rad found that Lot 301481 has a lower specificity (94.5%) than the 97.8% stated in the instructions, which could lead to more false positives.
The test may incorrectly indicate a positive result for conditions it shouldn't, potentially leading to unnecessary health concerns.
The recall record does not mention any remedy or corrective action.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-1377-2023 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-1377-2023 from Bio-Rad. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
