Abbott Optium EZ Blood Glucose Meters Recalled for Uncleared Disinfection Instructions
Abbott is recalling Optium EZ Blood Glucose Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA, posing a risk of 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 (infection) where injury has not yet been reported, and the agency classification is Class II without specific hospitalization reports.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling the Optium EZ Blood Glucose Monitoring System (UDI: 00093815710653). The recall is due to instructions for disinfecting blood glucose and/or ketone meters that 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. This may cause infection or exacerbation of an existing infection. The recall affects devices distributed in the following U.S. states and districts: 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.
Consumers should stop using the affected devices and follow the instructions provided by Abbott Diabetes Care, Inc. for the recall.
The recalled product
- Product
- Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
- 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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