Abbott Diabetes Care, Inc. recalls Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653

Recall date

November 14, 2019

Source

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

Recall number

Z-1557-2020

FDA classification

Class II

Brand / firm

Abbott Diabetes Care, Inc.

Sold / distributed

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

Why it was recalled

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.

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

What was recalled

Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653