Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Brand
Bio-Rad Laboratories, Inc.
Lot Codes / Batch Numbers
Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
Products Sold
Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
Bio-Rad Laboratories, Inc. is recalling BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack due to Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as inter. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Recommended Action
Per FDA guidance
On 02/08/2022, the firm sent out an "UGENT: Medical Device Correction" letter to customers via overnight FedEx informing them that the Recalling Firm continues to receive reports of false reactive RPR results despite labeling revisions and the previous Technical Bulleting dated December 2021 (LB003034revA). This is in response to ongoing concerns related to COVID-19 vaccine interference with RPR and the stability issue that led to the short dating of lot, the Recalling Firm is taking the additional field action to disable the RPR portion of the Syphilis Total and RPR panels until further notice. Customers are instructed to: 1. Dispose of the reagents according to local waste management procedures. 2. If they have further distributed or transferred the product to other customers, or labs from their site, notify those customer of this field action. 3. Complete Customer Response Form and email or fax the complete response form to local Bio-Rad Technical Support or email or fax the complete response form to your local Bio-Rad Technical Support. Please return this form to Techsupport.ussd@bio-rad.com or the Toll Free Fax 1-888-228-0688 within 10 days of receiving this notice. within 10 days of receiving this notice. The firm will be disabling (turn off the RPR analyte in the software) the RPR assay beginning with the reagent (Lot No. 301399 and calibrator (Lot No. 53440). If customers laboratory use of this reagent and calibrator, they will be unable to report RPR results. Customers are provided with directions for turning off the RPR analyte (see specific instructions attached to Customer Notification Letter). For questions or assistance, contact Bio-Rad Technical Support at email or fax the complete response form to your local Bio-Rad Technical Support. Please return this form to Techsupport.ussd@bio-rad.com or the Toll Free Fax 1-888-228-0688
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