Reported Jun 3, 2020 · Terminated

ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the…

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?

    • ISE Electrolyte Reference (2 X 2L) Reagent
    • REF A28937
  • UDI15099590202491 -
  • Product Usageare intended for the quantitative determination of carbon dioxide in human serum or plasma
Lot codes and dates
  • Lot NumberM909206
Amount recalled
2738 vials

Where it was sold

Why it was recalled

Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lead to delay in treatment.

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 28, 2021 · Data as of Sep 19, 5:24 PM UTC

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