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) ReagentREF 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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