Class 2 Device Recall BioPlex 2200 Syphilis Total & RPR

• Date Initiated by Firm: September 17, 2021
• Create Date: November 16, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0236-2022
• Recall Event ID: 88874
• 510(K)Number: K170413
• Product Classification: Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
• Product: BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
• Code Information: Catalog Number: 12000651 UDI Code: 03610520652770 Lot Number: 52953
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc.; 6565 185th Ave Ne; Redmond WA 98052-5039
• For Additional Information Contact: Tina Cuccia; 510-741-6063
• Manufacturer Reason for Recall: Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 09/17/2021, the Recalling Firm sent an "URGENT PRODUCT NOTIFICATION" Letter to customer via overnight FedEx informing them of two issues their Syphilis Total and RPR (Rapid Plasma Reagin) kits: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure. Customer are instructed to: -Immediately discontinue use and dispose of any unused product of reagent packs and calibrator set according to local waste management procedures. -Complete the customer response form and return it to their local Recalling Firm Technical Support, or 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.. -If the affected products have been further distributed or transferred, notify those customers of the field action. For additional questions, contact local Bio-Rad Technical Support.
• Quantity in Commerce: 791 units
• Distribution: Worldwide Distribution: U.S.(nationwide) including 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan.
• 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