Class 2 Device Recall BioPlex 2200 Syphilis Total & RPR

• Date Initiated by Firm: February 08, 2022
• Create Date: March 16, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0807-2022
• Recall Event ID: 89684
• 510(K)Number: K170413
• Product Classification: Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
• Product: BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
• Code Information: Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262
• FEI Number: 3008272466
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc.; 6565 185th Ave Ne; Redmond WA 98052-5039
• For Additional Information Contact: Tina Cuccia; 425-498-1758
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 724 Calibrator sets (U.S.)
• Distribution: Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.
• 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