FDA Medical Device Recalls (openFDA)
Roche Diabetes Care, Inc.: Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
- Recall number
- Z-2354-2021
- Recalling firm
- Roche Diabetes Care, Inc.
- Product
- Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
- Status
- Open, Classified
- Initiated
- 2021-07-28
- Posted
- not on file
- Terminated
- not on file
- Reason
- Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
- Root cause
- Package design/selection
- Action
- On July 28, 2021, the firm issued an Urgent Medical Device Correction to affected customers regarding the potential for open vials. Customers were warned that open vials may expose the test strips to humidity, which might damage the strips and result in inaccurate results (such as positively biased or falsely too high results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences. ACTIONS REQUIRED BY USERS: 1. Check vials of affected test strips before use. DO NOT use test strips if: - The vial is open or damaged before using the test strips for the first time - The cap is not fully closed - You see any damage to the cap or vial, or - Anything prevents the cap from closing properly 2. DO NOT perform control testing if you open a sealed carton and ay of the vials inside meet the criteria listed above. 3. Contact Accu-Chek Customer Care for product replacement if you open a sealed carton and any of the vials inside meet the criteria listed above by phone at 1-800-858-8072 or on our website at Accu-Chek.com under Contact Us for email or chat. Please have the affected products available. 4. Complete and return the business reply letter to the recalling firm. 5. Dispose of the affected test strips and vial according to your local guidelines. Contact Accu-Chek Customer Care if you have questions regarding the information in this Urgent Medical Device Correction(UMDC) by phone at 1-800-858-8072 or on our website at Accu-Chek.com under Contact Us for email or chat.
- Quantity
- 9,555,555 (US); 5,128,758 (OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Lot, serial or model codes
- Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
- 510(k) numbers
- ["K121679"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3011393376
- Firm city
- Indianapolis
- Firm state
- IN
- 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