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

Lot Number 301063

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.

• Brand Name: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Type of Device: BIORAD VIOPLEX 2200 SYPHILIS TOTAL AND RPR
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.
• MDR Report Key: 9693598
• MDR Text Key: 178756683
• Report Number: MW5092883
• Device Sequence Number: 2
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 301063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1