• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. BIOPLEX 2200 ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIO-RAD LABORATORIES, INC. BIOPLEX 2200 ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
Covid vaccine possibly caused false positive result with syphilis lab test. Original lab test that was conducted on (b)(6) was reactive minimal. I had another lab rpr, rfx qn rpr/confirm tp-012005 and the result was negative. I received moderna covid vaccine on (b)(6). Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOPLEX 2200
Type of DeviceENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
Manufacturer (Section D)
BIO-RAD LABORATORIES, INC.
MDR Report Key13093186
MDR Text Key282898791
Report NumberMW5106283
Device Sequence Number1
Product Code LIP
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/27/2021 Patient Sequence Number: 1
-
-