Recall Z-1556-2020
Abbott Diabetes Care, Inc. · initiated November 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Codes / lots: Not associated with specific model/lot numbers.
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: 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.
Details
- Recall number
- Z-1556-2020
- Initiated
- November 14, 2019
- Posted by FDA
- February 28, 2020
- Terminated
- April 28, 2021
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- 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
- Recalling firm
- Abbott Diabetes Care, Inc., Alameda, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1557-2020 Class II | Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters… | 11/14/2019Terminated |
| Z-1558-2020 Class II | FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters… | 11/14/2019Terminated |