FDAFDA · Food and drugs·Recall number Z-1556-2020
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Published April 1, 2020 · Recall initiated: November 14, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Diabetes Care, Inc.
- Distributor
- 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
- Not associated with specific model/lot numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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