BioPlex 2200 6653250Recalls & reported problems
Bio-Rad Laboratories, Inc. · Anti-CCP Reagent Pack · Class 2
All models of BioPlex 2200 (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847865000857), received between Feb 22, 2023 and Feb 22, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 21, 2023Class IIOpen, Classified
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.
Z-1377-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2023False Positive Result; False Positive Result
BIO-RAD LABORATORIES HAS RECEIVED REPORTS OF DISCREPANT RESULTS WITH LOT NO. 301481 FROM FOUR CUSTOMERS PERFORMING LOT-TO-LOT VALIDATION AGAINST PREVIOUS LOTS. INTERNAL TESTING AT BIO-RAD HAS DEMONSTRATED THAT LOT NO. 301481 EXHIBITS A REDUCTION IN SPECIFICITY (POTENTIAL FOR FALSE POSITIVE RESULTS). THERE WERE NO REPORTED ADVERSE EVENT WITH THIS LOT. HOWEVER,FALSE POSITIVE ANTI-CCP RESULTS COULD LEAD TO INCORRECT DIAGNOSIS OF RHEUMATOID ARTHRITIS AND UNNECESSARY MEDICAL TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16422988 ↗
Other ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) devices
- Phadia 2500EE 12-4100-02Phadia AB · ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)1 recall0 reports
- Alinity 09P2720Abbott GmbH · ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)1 recall0 reports
- IMMUNOSCAN CCPlus RA-96PLUSSvar Life Science AB · Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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