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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM BIORAD VIOPLEX 2200 SYPHILIS TOTAL AND RPR

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BIO-RAD LABORATORIES, INC. ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM BIORAD VIOPLEX 2200 SYPHILIS TOTAL AND RPR Back to Search Results
Lot Number 301023
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Since initiation of using biorad bioplex 2200 syphilis total and rpr reagent pack the positivity rate has dramatically increased, while confirmation testing has revealed large number of (b)(6). Fda safety report id # (b)(4). Fda received date 02/06/2020.
 
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Brand NameENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
Type of DeviceBIORAD VIOPLEX 2200 SYPHILIS TOTAL AND RPR
Manufacturer (Section D)
BIO-RAD LABORATORIES, INC.
MDR Report Key9693598
MDR Text Key178756683
Report NumberMW5092883
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/06/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number301023
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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