Reported Nov 18, 2015 · Terminated

Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human…

Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Lot codes and dates
  • 595027 595029
Amount recalled
11,406 units total (1,660 units)

Where it was sold

  • Nationwide

Why it was recalled

Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

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

Notice updated Apr 13, 2016 · Data as of Sep 19, 5:59 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.