BioPlex 2200 12000650Recalls & reported problems
Bio-Rad Laboratories, Inc. · BioPlex 2200 Syphilis Total & RPR Reagent Pack · Class 2
All models of BioPlex 2200 (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03610520653012), received between Oct 9, 2021 and Oct 9, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “False Positive Result” (1 report).
3 FDA recall records name this device's identifier, 3 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 8, 2022Class IIOpen, Classified
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Z-0806-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 17, 2021Class IIOpen, Classified
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
Z-0235-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Apr 21, 2020Class IIOpen, Classified
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Z-2982-2020 · Root cause: Unknown/Undetermined 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.
InjuryOct 9, 2021False Positive Result; False Positive Result
A LABORATORY REPORTED THAT SAMPLES FROM A PATIENT TESTED ON THE BIOPLEX 2200 SYPHILIS TOTAL & RPR KIT IN (B)(6) AND (B)(6) 2021 WERE (B)(6) TOTAL AND (B)(6) ASSAYS. THE SAMPLES WERE SENT OUT FOR CONFIRMATORY TESTING AT (B)(6) LABS WITH AN ELISA SYPHILIS IGG ASSAY AND AT BOTH TIMES, THE SAMPLES WERE (B)(6). THE PHYSICIAN DECIDED TO ADMINISTER PENICILLIN TO THE PATIENT BASED ON THE BIOPLEX RESULTS. HOWEVER, THE PHYSICIAN EXPRESSED CONCERN THAT THE BIOPLEX RESULTS WERE (B)(6), WHILE THE (B)(6) RESULTS FROM (B)(6) WERE (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12602404 ↗
Other ANTIGENS, NONTREPONEMAL, ALL devices
- BD Macro-Vue™ RPR™ Card Test, Kit No. 110 275005Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL18 reports
- BD BBL™ VDRL Antigen 240765Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL3 reports
- BD Macro-Vue™ RPR™ Card Antigen Suspension 270309Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL3 reports
- BD Macro-Vue™ RPR Card Test 275130Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL2 reports
- BD Macro-Vue™ RPR™ Card Antigen Suspension 270333Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL1 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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