BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of
Check against the official notice below — it lists the full affected range.
Bio-Rad Laboratories is recalling the BioPlex 2200 Syphilis Total & RPR Reagent Pack (Catalog Number 12000650, Lot Number 301210), a test kit used to detect syphilis antibodies. The recall affects 11,610 units distributed nationwide across the U.S. and in France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan. The kit has two issues: customers reported higher than expected false positive RPR results that do not confirm with follow-up treponemal antibody tests, and routine stability testing found an increase in bias above acceptable levels that could cause elevated RPR reactivity, potentially from early shelf-life failure.
The recall notice does not specify what action affected consumers or healthcare facilities should take regarding this product.
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: 11,610 units Lot/code info: Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.