Bio-Rad Laboratories, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bio-Rad Laboratories, Inc.
Lot Codes / Batch Numbers
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).
Products Sold
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).
Bio-Rad Laboratories, Inc. is recalling BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:036105206530 due to The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026