FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: ACCU-CHEK Compact Care Kit; catalog number 3149137.
- Recall number
- Z-0977-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- ACCU-CHEK Compact Care Kit; catalog number 3149137.
- Status
- Terminated
- Initiated
- 2005-05-18
- Posted
- 2005-07-12
- Terminated
- 2005-12-12
- Reason
- The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.
- Root cause
- Other
- Action
- A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.
- Quantity
- not on file
- Distribution
- Nationwide.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K022171"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 1823260
- 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