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.
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: "Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter…"
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…
- 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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