OneTouch Ultra Test Strips Recalled for Potential Inaccurate Glucose Readings
Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 device with no reported illnesses or injuries. Temperature-induced defect in a critical medical measurement device with potential for patient harm if inaccurate results go undetected.
Plain-English summary
OneTouch Ultra Test Strips, 25-count boxes (item number 3510443), are being recalled by Cardinal Health Inc. due to temperature excursions that occurred during shipment.
During shipping, the devices were exposed to temperatures of 31.9°F intermittently over a 2-hour and 15-minute period. This temperature exposure may cause the test strips to produce inaccurate glucose readings.
The recall affects all lots shipped between February 23, 2021 and March 10, 2021 (NDC/UPC 353885994255), distributed nationwide in Florida, Georgia, and South Carolina.
Patients who have used affected strips should consult with their healthcare provider about the reliability of their glucose readings. Those with unused strips from affected lots should discontinue use and contact their healthcare provider or pharmacist.
The recalled product
- Product
- ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
- Manufacturer
- Cardinal Health Inc.
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: 353885994255 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
Part of a larger recall action
This product is one of 14 recalled by Cardinal Health 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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