FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
- Recall number
- Z-0513-2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
- Status
- Terminated
- Initiated
- 2011-11-17
- Posted
- 2012-01-11
- Terminated
- 2014-08-26
- Reason
- Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens healthcare Diagnostics initiated their recall of lot 1DD085 on November 17, 2011 by sending an Urgent Field Safety Notice letter to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the CTNI CAL lot 1DD085.
- Quantity
- 2281 cartons
- Distribution
- Worldwide distribution, including USA, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Slovenia, South Korea, Spain and Switzerland.
- Lot, serial or model codes
- Lot number 1DD085
- 510(k) numbers
- ["K081683"]
- PMA numbers
- not on file
- Product code
- JIT
- 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