Beckman Coulter Inc. recalls ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quant…

Recall date

January 29, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2136-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries of CANADA, JAPAN, LEBANON, SAUDI ARABIA, TAIWAN.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.