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.
Check against the official notice below — it lists the full affected range.
Bio-Rad Laboratories, Inc. is recalling the BioPlex 2200 Syphilis Total & RPR Calibrator Set (Catalog Number 12000651, Lot Number 52953) due to two issues. First, customers reported higher than expected Rapid Plasma Reagin (RPR) reactivity that did not confirm with treponemal antibody tests. Second, routine stability monitoring found an increase in mean bias above specification levels, which can cause elevated RPR reactivity and may indicate early shelf-life failure. The recalled product was distributed worldwide, including throughout the United States and in France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan. A total of 791 units were affected.
The BioPlex 2200 Syphilis Total & RPR Calibrator Set is used to calibrate syphilis testing equipment. The elevated RPR reactivity could lead to false positive syphilis test results. The recall notice does not specify what consumers or healthcare providers should do regarding affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 791 units Lot/code info: Catalog Number: 12000651 UDI Code: 03610520652770 Lot Number: 52953
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.