Lower riskMedical device recall · FDA · Published February 21, 2023
Bio-Rad BioPlex 2200 Anti-CCP Calibrator Set Recall: False Positive Risk
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.
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📍Recalling firmBio-Rad Laboratories, Inc.6565 185th Ave Ne · Redmond, WA 98052-5039
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/58862-bio-rad-bioplex-2200-anti-ccp-calibrator-set-recall-false.
“Bio-Rad BioPlex 2200 Anti-CCP Calibrator Set Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58862-bio-rad-bioplex-2200-anti-ccp-calibrator-set-recall-false. Based on FDA recall #Z-1378-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1378-2023%22&limit=1).
The FDA announced on Feb. 21, 2023, that Bio-Rad Laboratories is recalling the BioPlex 2200 Anti-CCP Calibrator Set due to reduced specificity that may cause false positive results. The agency issued recall number Z-1378-2023 for the Class II device.
Internal testing showed Lot No. 301481 has a specificity of 94.5%, lower than the indicated 97.8%. This reduction may lead to an increase in false positives. The calibrator lot #53727 is included because it is lot matched to the impacted reagent pack.
Context
GovInfoNow's records show Bio-Rad Laboratories has had 12 other recalls since April 2, 2018. Recent Bio-Rad recalls include a May 30, 2025 Platelia Toxo IgM Kit recall for false positive risks and a Feb. 28, 2023 BioPlex 220 recall for incorrect reagents. Other recent recalls of similar products include the Oct. 22, 2025 BioFire Respiratory Panel 2.1 Recall for false negatives risk and the April 22, 2026 BioFire Joint Infection Panel Recall for false positives risk.
How to tell if you have this one
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.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
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.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1378-2023 (February 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1378-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.