Abbott FreeStyle InsuLinx Blood Glucose Meter Recall for Inaccurate Readings
Abbott is recalling FreeStyle InsuLinx meters because they may provide inaccurate readings at rare, extremely high glucose levels (1024 mg/dL and above).
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 source text explicitly identifies the agency classification as Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Abbott Diabetes Care, Inc. is recalling the FreeStyle InsuLinx Blood Glucose Monitoring System. The recall involves 335,273 meters, with 209,336 remaining at the firm. The products were distributed nationwide.
The recall is due to a potential for inaccurate readings at rare, extremely high glucose levels, specifically 1024 mg/dL and above. The affected meters include part numbers 71142-70, 71143-70, 71145-70, and 71150-70, across all serial and lot numbers.
Consumers should stop using the affected meters and contact Abbott Diabetes Care, Inc. for further instructions. The agency has classified this as a Class I recall.
The recalled product
- Product
- FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with…
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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