Abbott FreeStyle Precision H Blood Glucose and Ketone Meter Recall
Abbott is recalling FreeStyle Precision H meters because unapproved instructions for disinfection and multi-patient use may 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 (infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling the FreeStyle Precision H Blood Glucose and Ketone Monitoring System. The recall involves all lots of the device. The products were distributed in the District of Columbia and 30 states, including California, Florida, New York, and Texas.
The recall was initiated because instructions for disinfecting the meters and for using them with multiple patients were distributed without clearance from the U.S. Food and Drug Administration. The devices were not cleared for multiple-patient use. Following these unapproved instructions could result in inappropriate disinfection or improper handling of contaminated meters, which may cause infection or worsen an existing infection.
Consumers should stop using the device if they have received these specific instructions. They should contact Abbott Diabetes Care, Inc. for further guidance on how to proceed.
The recalled product
- Product
- FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
- 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)
- All lots.
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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