FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
- Recall number
- Z-0737-2007
- Recalling firm
- Roche Diagnostics Corp.
- Product
- CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
- Status
- Terminated
- Initiated
- 2007-02-28
- Posted
- 2007-04-11
- Terminated
- 2007-06-13
- Reason
- The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
- Root cause
- Other
- Action
- All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
- Quantity
- 10
- Distribution
- Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
- Lot, serial or model codes
- Lots 469A and 475A; exp. 6/30/2008.
- 510(k) numbers
- ["K930454","K962571","K974569","K994349"]
- 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