Reported Mar 22, 2017 · Terminated

The ABL800 Model#:All

Radiometer America 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: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • The ABL800 Model#:All
Lot codes and dates
  • The affected analyzers are serial numbers 393-090R0027N001 to present.
Amount recalled
17,522

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

  • Nationwide

Why it was recalled

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

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 Feb 20, 2018 · Data as of Sep 19, 4:46 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.