Reported Sep 9, 2015 · Terminated

COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze…

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 LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Lot codes and dates
  • Lot Numbers
    • 510376F-510657F
    • M405229-M503553
Amount recalled
409,042 units (339,545 units in US)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.

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 Dec 18, 2015 · Data as of Sep 19, 5:26 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.