FDAFDA · Food and drugs·Recall number Z-2136-2020
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.
Published June 3, 2020 · Recall initiated: January 29, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- Lot Number: M909206
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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