Abbott Precision Xtra Blood Glucose Meters Recalled for Uncleared Disinfection Instructions
Abbott is recalling Precision Xtra Blood Glucose & Ketone Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA and could lead to infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is infection or exacerbation of existing infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling the Precision Xtra Blood Glucose & Ketone Monitoring System (UDI: 00093815715023, 00093815988144). The recall involves instructions sent in a letter or included in the instructions for use regarding the disinfection of blood glucose and/or ketone meters.
The recall was initiated because these specific instructions were distributed but not cleared by the U.S. Food and Drug Administration. Additionally, the devices were not cleared for multiple-patient use. The unapproved instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbate an existing infection.
The affected products were distributed in the following U.S. states and district: 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. The recall is not associated with specific model or lot numbers. Consumers should stop using the unapproved instructions and follow the manufacturer's guidance for proper device handling.
The recalled product
- Product
- Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
- Manufacturer
- Abbott Diabetes Care, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Not associated with specific model/lot numbers.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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