# FDA recall Z-0236-2022

> **Bio-Rad Laboratories, Inc.** · Class II · device recall initiated 2021-09-17.

## 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.

## 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-0236-2022
- **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-0236-2022

## Citation

> AI Analytics. FDA recall Z-0236-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0236-2022. Source: US FDA. Licensed CC0.

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