OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
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: FDA Class II recall of blood glucose testing lancets with potential for inaccurate results from temperature exposure. No injuries or illnesses reported, and the hazard is theoretical, so per rubric criteria this qualifies as High (3) severity.
Plain-English summary
CardinalHealth, Inc. is recalling 2,315 boxes of OneTouch Delica Lancets, 30G, 100-count because they were exposed to freezing temperatures during shipping. During transit, the devices experienced temperature drops to 31.9°F over intermittent 2-hour periods, which may cause inaccurate blood glucose test results.
The affected product (NDC/UPC: 812608030026) was distributed in Florida, Georgia, and South Carolina. All lot numbers shipped from February 23 through March 10, 2021 are included in the recall.
If you have used these lancets, monitor your blood glucose readings closely and verify device integrity. Contact your healthcare provider or manufacturer if you have concerns about whether your devices are affected.
The recalled product
- Product
- ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
- Manufacturer
- Cardinal Health Inc.
- Hazard
- temperature-degradation
- 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: 812608030026 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
Distributed nationwide across the United States.
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