Reported Sep 24, 2014 · Terminated

Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution…

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?

  • Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.
Lot codes and dates
    • Lot No. 3510470
    • 3510480
    • 3510490
    • 3510500
    • 3510510
    • 3510520
    • 3510530
    • 3510540
    • 3510550
    • 3510570
    • 3510580
    • 3510590
    • 3510600
    • 3510610
    • 3510620
    • 3510630
    • 3510690
Amount recalled
46,050 units total (40,078 units in US)

Where it was sold

  • Nationwide

Why it was recalled

Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.

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 25, 2015 · Data as of Sep 19, 6:52 PM UTC

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