FDA Medical Device Recalls (openFDA)
Dade Behring, Inc.: Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
- Recall number
- Z-0668-2009
- Recalling firm
- Dade Behring, Inc.
- Product
- Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2008-06-23
- Posted
- 2009-01-28
- Terminated
- 2009-01-29
- Reason
- Incorrect result: Potential for false elevation of CTnI results
- Root cause
- Nonconforming Material/Component
- Action
- Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.
- Quantity
- 5868 cartons
- Distribution
- Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
- Lot, serial or model codes
- Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.
- 510(k) numbers
- ["K051650"]
- PMA numbers
- not on file
- Product code
- JHX
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- 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