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Abbott Diabetes Care, Inc. recalls FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Recalled April 1, 2020 · FDA recall Z-1558-2020 · 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
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Manufacturer(s)
Abbott Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →