03/24/2022: Lab Alert: BioRad Recalls RPR Portion of the BioPlex 2200 Syphilis Total & RPR Test Kit

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Facilities Using the BioPlex 2200 Syphilis Total & RPR Test Kit

Level: Laboratory Alert

On February 8, 2022, BioRad issued a voluntary recall for the RPR portion of the BioPlex 2200 Syphilis Total & RPR Test Kit. The U.S. Food and Drug Administration (FDA) classified this as a Class 2 Device Recall on March 16, 2022.

In response to concerns related to COVID-19 vaccine interference and false reactive RPR (Rapid Plasma Reagin; non-treponemal) results, BioRad Laboratories, Inc. has disabled the RPR portion of the Syphilis Total and RPR panels until further notice.

Individuals who need syphilis testing should continue to get tested and receive the full testing algorithm.

We encourage you to review this recall notice in detail.

Share this message widely with your networks and invite them to opt in to LOCS to receive future updates.

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Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: March 24, 2022