Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay Recalled by Bio-Rad Laboratories, Inc. Due to The increased level of RPR reactivity in the...

Date: April 21, 2020
Company: Bio-Rad Laboratories, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bio-Rad Laboratories, Inc. directly.

Affected Products

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.

Quantity: 12000 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bio-Rad Laboratories, Inc.

Bio-Rad Laboratories, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report