Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
- Company
- Abbott Diabetes Care, Inc.
- Recall Initiated
- November 14, 2019
- Posted
- February 28, 2020
- Terminated
- April 28, 2021
- Recall Number
- Z-1557-2020
- Firm Location
- Alameda, CA
Reason for Recall
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.
Distribution
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
Lot / Code Info
Not associated with specific model/lot numbers.
Root Cause
Labeling False and Misleading
Action Taken
On 11/14/19, Urgent Medical Device Correction notices were mailed to customers via overnight delivery. Customers were told to continue to use instructions for use regarding the cleaning of meters for use on single patients only. Customers were further asked to complete and return customer response forms. Customers with additional questions were encouraged to call customer service in 1-888-522-5226.