FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
- Recall number
- Z-0069-2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
- Status
- Terminated
- Initiated
- 2011-08-31
- Posted
- 2011-10-19
- Terminated
- 2014-01-14
- Reason
- Firm has confirmed customer complaints for low recovery of QC and patient samples.
- Root cause
- Process control
- Action
- Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.
- Quantity
- 6,072 cartons
- Distribution
- Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.
- Lot, serial or model codes
- Lot Numbers ED2098, EA2111, FB2134, ED2147
- 510(k) numbers
- ["K081643"]
- PMA numbers
- not on file
- Product code
- JJE
- 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