FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche brand Cardiac Reader.
- Recall number
- Z-0383-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche brand Cardiac Reader.
- Status
- Terminated
- Initiated
- 2004-12-03
- Posted
- 2005-01-06
- Terminated
- 2005-09-08
- Reason
- Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
- Root cause
- Other
- Action
- User hospitals were notified via phone, letter and fax (beginning on 12/3/04) a copy of the recall notification on December 3, 2004, which instructed them to immediately cease using the device. The firm issued a press release on December 8, 2004.
- Quantity
- 95
- Distribution
- United States.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K000784"]
- PMA numbers
- not on file
- Product code
- not on file
- 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