OneTouch Ultra Blue test strips recalled for temperature exposure damage
Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate 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: This is a medical device recall where temperature damage poses a documented risk of harm to diabetic patients relying on accurate blood glucose readings for treatment decisions. No illnesses or injuries have been reported. The FDA Class II classification with a tangible hazard but no reported harm aligns with the rubric criterion for High severity.
Plain-English summary
Cardinal Health Inc. is recalling 5,356 boxes of OneTouch Ultra Blue test strips (100-count, Item Number 2990174). The recall affects all lot numbers shipped between February 23, 2021 and March 10, 2021, identified by NDC/UPC 353885009713.
During shipping delays, the devices were exposed to temperature excursions of 31.9°F, occurring intermittently over a 2-hour and 15-minute period. This temperature exposure may cause the test strips to produce inaccurate results.
The affected products were distributed in Florida, Georgia, and South Carolina. Consumers who possess these test strips should discontinue use and consult their healthcare provider. Inaccurate glucose readings could lead to improper insulin dosing or other incorrect treatment decisions.
The recalled product
- Product
- ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
- Manufacturer
- Cardinal Health Inc.
- Hazard
- inaccurate-results
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 (1)
- NDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
Distributed nationwide across the United States.
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