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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when…"
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…
- 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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