Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Precision Xtra Blood Glucose & Ketone Monitoring System Recalled by Abbott Diabetes Care, Inc. Due to Instructions sent in a letter or in instructions...

Date: November 14, 2019
Company: Abbott Diabetes Care, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Diabetes Care, Inc. directly.

Affected Products

Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144

Quantity: N/A

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 32 states: 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

Affected (32 states)Not affected

About Abbott Diabetes Care, Inc.

Abbott Diabetes Care, Inc. has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report