OneTouch Ultra Blue recallZ-1936-2021 · Cardinal Health Inc. · initiated Mar 16, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
FDA root cause category: Environmental control
What the company is doing
On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements. Actions Required 1. INSPECT your inventory for the affected product. 2. SEGREGATE and QUARANTINE all affected product. 3. RETURN the enclosed acknowledgment form via fax to 1-817-868-5362 or email to [email protected], even if you do not have any product on hand. 4. CONTACT Inmar to arrange for return and credit of any affected product: 1-855-696-2074 (9:00 AM to 5:00 PM, Monday thru Friday)
Recall details
- Recall number
- Z-1936-2021
- Status
- Open, Classified
- Initiated by the company
- Mar 16, 2021
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 5,356 boxes of 100 strips
- Product code
- NBW
- FDA submissions
- K062195
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
Product description
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Code information (models, lots, serial numbers)
NDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OneTouch Ultra Blue 022-895LifeScan U.S. LLC · GLUCOSE OXIDASE, GLUCOSE1 recall7 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87787).
- Z-1929-2021 · Open, ClassifiedFREESTYLE LANCETS 28G 100CT Item Number:2975670
- Z-1931-2021 · Open, ClassifiedFREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
- Z-1935-2021 · Open, ClassifiedVAPORIZER VICKS 1.5GAL Item Number: 2354942
- Z-1937-2021 · Open, ClassifiedONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
- Z-1938-2021 · Open, ClassifiedONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
- Z-1939-2021 · Open, ClassifiedONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
- Z-1940-2021 · Open, ClassifiedONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
- Z-1942-2021 · Open, ClassifiedACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page