Bio-Rad Laboratories, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0807-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Product Classification:

Class II

Date Initiated: February 8, 2022

Date Posted: March 23, 2022

Recall Number: Z-0807-2022

Event ID: 89684

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

Status: Ongoing

Product Quantity: 724 Calibrator sets (U.S.)

Code Information:

Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated