Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Results
Abbott Diabetes Care is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.
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 produces erroneous results posing significant health risks, but the source text does not report specific injuries, hospitalizations, or deaths, nor does it explicitly classify the recall as FDA Class I or II.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips. The affected products include 50-count cartons for human use and institutional use, manufactured in Alameda, California. The recall covers 141,219 cartons distributed nationwide in the United States, Puerto Rico, and internationally to numerous countries including Australia, Canada, and the United Kingdom.
The recall is being issued because certain lots of these test strips produce erroneously low blood glucose results when used with FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters, or the FreeStyle blood glucose meter built into the OmniPod system. The source text states that erroneously low results that are not recognized may pose significant risks to health.
Consumers and healthcare professionals should stop using the affected test strips immediately. The specific affected lots are identified by part number 12050-21 (Lot 1285007, Exp. 2014/06) and part number 70792-20 (Lot 1373262, Exp. 2015/02). Users should check their product packaging for these specific lot numbers and expiration dates to determine if their products are affected.
The recalled product
- Product
- FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Bloo
- Manufacturer
- Abbott Diabetes Care, Inc.
- Affected units
- 141,219
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 (3)
- Part number 12050-21: Lot number: 1285007 Exp. date: 2014/06
- Part number 70792-20 (instuitional use) Lot number: 1373262
- Exp. Date 2015/02
Distribution
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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