Abbott FreeStyle Blood Glucose Monitors Recalled for Inaccurate Results
Abbott Diabetes Care is recalling FreeStyle Blood Glucose Monitors because they may produce inaccurate blood glucose readings when used with specific test strips.
What this means for you
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 medical device that may produce erroneously low blood glucose results, posing a risk of harm to patients relying on accurate readings for insulin management. No injuries or illnesses are reported in the source text, and the agency classification is Class I, which typically corresponds to a High severity score when no adverse events are documented.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling FreeStyle Blood Glucose Monitors. The recall affects all non-applied voltage legacy meters, identified by part number CAT11001-0 and all serial numbers. The devices were distributed worldwide, including in the United States, Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, and the United Kingdom.
The recall was initiated after internal testing and investigation revealed that these 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 that are within their expiry date. The FreeStyle meter is also incorporated into the OmniPod insulin management system.
Consumers should stop using the affected FreeStyle Blood Glucose Monitors immediately. Users should contact Abbott Diabetes Care for further instructions on how to return the device or obtain a replacement. The source text does not specify a specific return deadline or contact method.
The recalled product
- Product
- FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed
- 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 (2)
- Part number CAT11001-0
- 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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