Recall Z-1558-2020 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Abbott Diabetes Care, Inc.
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
| Date | Feb 28, 2020 (initiated Nov 14, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| FDA record | Open on fda.gov |