FDA Medical Device Recalls (openFDA)
Cardinal Health Inc.: ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
- Recall number
- Z-1942-2021
- Recalling firm
- Cardinal Health Inc.
- Product
- ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
- Status
- Open, Classified
- Initiated
- 2021-03-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Environmental control
- Action
- 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 rxrecalls@inmar.com, 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)
- Quantity
- 537 boxes of 100 strips
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
- Lot, serial or model codes
- NDC/UPC: 365702493100 All lots shipped from 2/23/201 to 3/10/2021
- 510(k) numbers
- ["K113137"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3004008697
- Firm city
- Dublin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28