# FDA recall Z-0807-2022

> **Bio-Rad Laboratories, Inc.** · Class II · device recall initiated 2022-02-08.

## Product

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

## Reason for recall

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

## Distribution

Worldwide distribution U.S. Nationwide distribution in the 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.

## Key facts

- **Recall number:** Z-0807-2022
- **Recalling firm:** Bio-Rad Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-08
- **Report date:** 2022-03-23

- **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-0807-2022

## Citation

> AI Analytics. FDA recall Z-0807-2022. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-0807-2022. Source: US FDA. Licensed CC0.

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