medical Class II Updated 2020-04-01

Abbott Diabetes Care, Inc. recalls Optium EZ Blood Glucose Monitoring System, UDI: 000938157106

Recalled Product

Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653

Hazard / Issue

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.

Issued by

FDA

Affected States: 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
Lot/Code Info: Not associated with specific model/lot numbers.
View official government recall

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