Reported Sep 6, 2017 · Terminated

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows…

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?

  • UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient
  • A stained blood filmAllows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities
Lot codes and dates
    • P/N A85371AA20
    • Catalog No. 775222
Amount recalled
310 units

Where it was sold

Why it was recalled

The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.

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 21, 2021 · Data as of Sep 19, 4:46 PM UTC

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