Abbott Diabetes Care, Inc. FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Brand
Abbott Diabetes Care, Inc.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Abbott Diabetes Care, Inc. is recalling FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, ME, MA, MN, MS, MO, MT, NE, NJ, NM, NY, NC, ND, OH, OK, PA, SC, TN, TX, VT, VA, DC
Page updated: Jan 10, 2026