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 REF 12000651 Syphilis Total & RPR Calibrator Set CAL Recalled by Bio-Rad Laboratories, Inc. Due to Due to current concerns related to COVID-19 vaccine...

Date: February 8, 2022
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 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Quantity: 724 Calibrator sets (U.S.)

Why Was This Recalled?

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

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