FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
- Recall number
- Z-0098-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
- Status
- Terminated
- Initiated
- 2005-03-28
- Posted
- 2005-10-28
- Terminated
- 2006-04-06
- Reason
- Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- Root cause
- Other
- Action
- Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
- Quantity
- unknown.
- Distribution
- Nationwide.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K021190","K030845","K962571"]
- PMA numbers
- not on file
- Product code
- GJS
- 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