FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
- Recall number
- Z-2400-2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
- Status
- Terminated
- Initiated
- 2010-04-13
- Posted
- 2010-09-11
- Terminated
- 2010-10-25
- Reason
- False elevated Stratus CS CTNI results
- Root cause
- Process control
- Action
- Recalling firm issued " Urgent Field Safety Notice" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009.
- Quantity
- 7500 cartons
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- lot# 239229002, EXP# 2/13/2010 lot# 239236002, EXP2/20/2010 lot# 239243002, EXP# 2/7/2010 lot# 239257002, EXP# 3/10/2010 lot# 239264002, EXP# 3/20/2010 lot# 239271002, EXP# 3/27/2010 lot# 239278002, EXP# 4/3/2010 lot# 239285002, EXP# 4/10/2010 lot# 239292002, EXP# 4/17/2010 lot# 239299002, EXP# 4/24/2010 lot# 239313002, EXP 5/8/2010 lot# 239334002, EXP 5/29/2010 lot# 239341002, EXP#6/5/2010 lot# 239362002, EXP# 6/26/2010
- 510(k) numbers
- ["K051650"]
- PMA numbers
- not on file
- Product code
- MMI
- 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