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Abbott Diabetes Care, Inc. recalls Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Recalled April 1, 2020 · FDA recall Z-1557-2020 · Abbott Diabetes Care
Hazard
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection. · FDA Class II
Units
N/A
Sold at
U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
Description
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Product
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Manufacturer(s)
Abbott Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →