Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 Syphilis Total & RPR 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
 


New Search Back to Search Results
  Class 2 Device Recall BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum see related information
Date Initiated by Firm April 21, 2020
Create Date September 18, 2020
Recall Status1 Open3, Classified
Recall Number Z-2982-2020
Recall Event ID 85636
510(K)Number K170413  
Product Classification Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
Product BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
Code Information The RPR assay will be disabled beginning with reagent lot 301142 and future manufactured lots of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). Product Code 1: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM (LIP), Product Code 2: ANTIGENS, NONTREPONEMAL, ALL (GMQ), Product Code 3: CALIBRATOR, SECONDARY (JIT), Product Code 4:SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX).  
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information Contact Tina Cuccia
425-881-8300
Manufacturer Reason
for Recall		 The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Consignees that have purchased active lots of the BioPlex 2200 Syphilis Total and RPR kit have been notified of the Field Correction via a customer letter sent via Fed Ex overnight ; date issued 04/21/2020. The communication was to inform that the RPR portion of the BioPlex 2200 Syphilis Total & RPR assay will be temporarily disabled. The RPR assay will be disabled beginning with reagent lot 301142 of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). The reporting of the RPR assay results will be disabled by the installation of a new assay protocol file (APF). The communication includes that there are no modifications to the chemistry of the assay reagents or processing of the assay by the BioPlex 2200 System. The RPR assay will remain disabled until further notice. Consignees are asked to complete and return the Customer Response form (fax: 1-888-228-0688/email: Techsupport.ussd@bio-rad.com) to confirm receipt of the communication and to receive instructions for installation of the new APF; return the form within 10 days of receiving the notice. Additionally, consignees are asked to contact their local technical support if there are any questions about the notification.
Quantity in Commerce 12000 kits
Distribution Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), France (FR), Italy (IT), Spain (ES), and Romania (RO), and United Kingdom (GB).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LIP and Original Applicant = Bio-Rad Laboratories
-
-