Bio-Rad Laboratories, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2982-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.

Product Classification:

Class II

Date Initiated: April 21, 2020

Date Posted: September 30, 2020

Recall Number: Z-2982-2020

Event ID: 85636

Reason for Recall:

The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.

Status: Ongoing

Product Quantity: 12000 kits

Code Information:

The RPR assay will be disabled beginning with reagent lot 301142 and future manufactured lots of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). Product Code 1: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM (LIP), Product Code 2: ANTIGENS, NONTREPONEMAL, ALL (GMQ), Product Code 3: CALIBRATOR, SECONDARY (JIT), Product Code 4:SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX).

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), France (FR), Italy (IT), Spain (ES), and Romania (RO), and United Kingdom (GB).

Voluntary or Mandated:

Voluntary: Firm initiated