Reported Mar 23, 2022 · Ongoing

BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Bio-Rad Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bio-Rad Laboratories, Inc. · 6565 185th Ave Ne · Redmond, WA · 98052-5039

Is this the product you have?

  • BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Lot codes and dates
  • Catalog Number12000650
  • UDI GTIN Code03610520653012
  • Lot Numbers301336
Amount recalled
9,426 packs (U.S.)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was 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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.