Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results
Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling 25,203 units of the FreeStyle Flash Blood Glucose Monitors System. The recall was initiated after internal testing and investigation identified that all non-applied voltage legacy meters have the potential to produce out-of-range control solution results or erroneously low blood glucose results. This issue occurs when the meters are used in conjunction with FreeStyle test strips lots that are within their expiry date.
The affected meters were manufactured in China and distributed by TheraSense in Alameda, California. The distribution pattern includes the United States (nationwide) as well as Austria, Canada, Germany, Israel, the Netherlands, Norway, Sweden, Switzerland, and the United Kingdom. The products are identified by Catalog Number 17002 and NDC 99073-0170-02, and the recall covers all serial numbers.
Consumers should stop using the affected FreeStyle Flash meters immediately. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death. Users should contact Abbott Diabetes Care for further instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
- Manufacturer
- Abbott Diabetes Care, Inc.
- Affected units
- 25,203
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)
- Catalog Number 17002 NDC 99073-0170-02. All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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