Bio-Rad recalls specific lot of BioPlex 2200 Anti-CCP Calibrator Set due to reduced specificity causing potential false positives in tests. Affected units have lot number 301481 and calibrator lot 53727. No immediate action required per recall.
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 positivesBio-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 positivesBio-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.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.
Bio-Rad is recalling a specific lot (301481) of BioPlex 2200 Anti-CCP Calibrator Set because it has lower specificity than stated, which could lead to more false positive test results. This affects laboratory users who perform tests with this kit. The recall does not require immediate action as the remedy is not specified.
The recalled lot (301481) shows a specificity of 94.5% instead of the stated 97.8%, meaning it may produce more false positive results when testing. This could lead to incorrect diagnoses if the test is used in clinical settings. The calibrator lot 53727 is included because it's lot-matched to the affected reagent pack.
Laboratory users who have the BioPlex 2200 Anti-CCP Calibrator Set with lot number 301481 or matched calibrator lot 53727. These users are most at risk if they rely on this kit for accurate test results.
Check for the lot number 301481 on the BioPlex 2200 Anti-CCP Kit. The calibrator lot 53727 is included in the recall because it's lot-matched to the affected reagent pack.
Look for the lot number 301481 on the BioPlex 2200 Anti-CCP Kit. The calibrator lot 53727 is also included in the recall as it's lot-matched to the affected reagent pack.
Bio-Rad received four customer complaints between November 30, 2022 and December 21, 2022 stating that results were discrepant when performing lot-to-lot validation. Internal testing showed the recalled lot (301481) has a specificity of 94.5% instead of the stated 97.8%.
The recall notice does not specify any remedy or action required.
Yes, the calibrator lot 53727 is included in the recall because it's lot-matched to the affected reagent pack (lot 301481).
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-1378-2023 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-1378-2023 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.
