# FDA recall Z-0235-2022 > **Bio-Rad Laboratories, Inc.** · Class II · device recall initiated 2021-09-17. ## Product 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 nontreponemal reagin antibodies in human serum or plasma ## 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. ## Key facts - **Recall number:** Z-0235-2022 - **Recalling firm:** Bio-Rad Laboratories, Inc. - **Classification:** Class II - **Product type:** device - **Status:** Ongoing - **Initiation date:** 2021-09-17 - **Report date:** 2021-11-24 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Redmond, WA, United States ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2022 ## Citation > AI Analytics. FDA recall Z-0235-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0235-2022. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*