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U.S. Department of Health and Human Services

Class 2 Device Recall Optium EZ Blood Glucose Monitoring System

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  Class 2 Device Recall Optium EZ Blood Glucose Monitoring System see related information
Date Initiated by Firm November 14, 2019
Date Posted February 28, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-1557-2020
Recall Event ID 84866
510(K)Number K081975  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Code Information Not associated with specific model/lot numbers.
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information Contact Naveen Thuramalla
510-239-2618
Manufacturer 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.
FDA Determined
Cause 2		 Labeling False and Misleading
Action 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.
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
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