Z-0513-2012

Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro...

Name: Z-0513-2012 Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2011-11-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-11-17 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic on 2011-11-17. The reason FDA records is "Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0513-2012
Status: Terminated
Initiated: 2011-11-17
Posted: 2012-01-11
Terminated: 2014-08-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
Product code: JIT Calibrator, Secondary
Reason for recall: Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot number 1DD085

Product code JIT

K081683Class IILoci Cardiac Troponin I Calibrator, Model Rc621Siemens Healthcare Diagnostics / cleared 2008-07-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)