BioPlex 2200Recalls & reported problems across all models

We found 8 models of BioPlex 2200 by Bio-Rad Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Oct 21, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 reports).

9 FDA recall records name at least one of these models by its device identifier, 9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BioPlex 2200 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 28, 2023Open, Classified

   APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

   Z-1572-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 21, 2023Open, 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 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.

   Z-1378-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 21, 2023Open, 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 ↗

4. Apr 14, 2022Open, Classified

   Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.

   Z-1096-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Feb 8, 2022Open, 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-0807-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Feb 8, 2022Open, 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 ↗

7. Sep 17, 2021Open, 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-0236-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

8. Sep 17, 2021Open, 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 ↗

9. Apr 21, 2020Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported BioPlex 2200 problems

BioPlex 2200 models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BioPlex 2200 12000650

  ANTIGENS, NONTREPONEMAL, ALL
  3 recalls1 report
• BioPlex 2200 12000651

  Calibrator, secondary
  3 recalls0 reports
• BioPlex 2200 6652050

  System,test,antibodies,b2 - glycoprotein i (b2 - gpi)
  1 recall1 report
• BioPlex 2200 6653250

  ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
  1 recall1 report
• BioPlex 2200 6633200

  Multi-analyte controls, all kinds (assayed)
  1 recall0 reports
• BioPlex 2200 12000670

  ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
  1 recall0 reports
• BioPlex 2200 6600000

  Instrumentation for clinical multiplex test systems
  4 reports
• BioPlex® 2200 6633435

  Test, Hiv Detection
  1 report

Recent BioPlex 2200 adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED BEING SPRAYED IN THE FACE WITH LIQUID FROM THE BIOPLEX 2200 INTERNAL WASTE OVERFLOW CONTAINER AFTER MANUALLY EMPTYING IT DURING ERROR 13211 (GENERAL PURPOSE WASTE - UNABLE TO PURGE). CUSTOMER HAS FLUSHED HER FACE AND EYES USING THE EYEWASH.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23351235 ↗
• MalfunctionMar 8, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  BIO-RAD LABORATORIES RECEIVED A CUSTOMER COMPLAINT REGARDING INTERMITTENT QC FAILURE WHEN RUNNING BIOPLEX 2200 APLS IGM REAGENT PACKS, LOT NO. 301538. BIO-RAD LABORATORIES DETERMINED THAT A SMALL PERCENTAGE OF THIS REAGENT PACK LOT WAS PACKAGED WITH THE INCORRECT CONJUGATE. THERE WERE NO REPORTED ADVERSE EVENT WITH THIS LOT. HOWEVER, THE USE OF REAGENT PACKS CONTAINING THE INCORRECT CONJUGATE MAY LEAD TO AN INCREASE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507633 ↗
• 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 ↗
• MalfunctionNov 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE BIOPLEX IS CONNECTED TO A INPECO LABORATORY AUTOMATION SYSTEM (TLA). A SAMPLE WAS ADDED TO THE QUEUE FOR SAMPLING ON BIOPLEX AND AN ERROR OCCURRED. 2 SAMPLES THAT WERE BEHIND THE FIRST SAMPLE WERE NOT MOVED TO THE GATING AREA OF THE BIOPLEX, BUT BIOPLEX SHOWED SAMPLES ARE IN PROCESS. THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853697 ↗
• MalfunctionOct 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE BIOPLEX IS CONNECTED TO A INPECO LABORATORY AUTOMATION SYSTEM (TLA). DUE TO AN ERROR AT THE ASPIRATION POSITION OF THE TLA, A SAMPLE TUBE BECAME STUCK IN THE TRACK LINE AT THE BIOPLEX GATING AREA. THE BIOPLEX PIPETTED FROM THE TUBE SEVERAL TIMES AND MISASSIGNED THE SAMPLE TO SUBSEQUENT ACCESSION NUMBERS. THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629585 ↗
• 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 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A CALL ON (B)(6) 2017. TECHNICIAN REPORTED THAT WHILE HE WAS RUNNING A SAMPLE ON SEPTEMBER (B)(6) 2017, HE RECEIVED AN ERROR MESSAGE. THE SAMPLE RACK WAS STUCK. HE REMOVED THE FRONT COVER TO TRY TO GET THE RACK OUT WITH SOME FORCE AND THAT IS WHEN HE CUT HIS HAND. HE WAS RUNNING HIV TEST ON THE SYSTEM.

  Patient problems: Injury

  MAUDE report 7113356 ↗
• Dec 13, 2016Human Factors Issue; Human Factors Issue

  THE CHEMISTRY SUPERVISOR ACCIDENTLY DROPPED ONE OF THE BIOPLEX 2200 AG-AB QUALITY CONTROL (QC) VIALS AND THE LIQUID SPLASHED TOWARDS HER EYES. THE OPERATOR WAS NOT WEARING ANY SORT OF PERSONAL PROTECTIVE EQUIPMENT (PPE), HOWEVER SHE WAS WEARING GLASSES. SOME OF THE LIQUID FROM THE QC VIAL DID SPLASH INTO ONE OF HER EYES. THE CHEMISTRY SUPERVISOR IMMEDIATELY SOUGHT CARE FROM ONE OF THE HOSPITAL NURSES FOR THE SPLASHED LIQUID IN HER EYE. ACCORDING TO THE NURSE, NO MEDICAL INTERVENTION WAS NECESSARY AT THAT TIME, SO NO INCIDENT REPORT WAS FILED BY THE LAB BECAUSE THEY DID NOT FEEL IT WAS NECESSARY DUE TO THE MINOR ACCIDENT. BIO-RAD LABORATORIES IS REPORTING THIS ADVERSE EVENT TO ENSURE THAT THE SPLASH HAS NO LONG TERM DAMAGE TO THE AFFECTED PERSON BECAUSE OF THE EXPOSURE TO THE BIOLOGICAL MATERIALS IN THE BIOPLEX 2200 AG-AB QUALITY CONTROL (QC) VIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6169746 ↗

Other Bio-Rad Laboratories, Inc. products

• Liquichek21 models · 23 reports