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.

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.

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 [email protected] 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.