Z-1926-2014Class II

Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro...

Name: Z-1926-2014 Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-09-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-09-17 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the... on 2013-09-17. FDA classified it as Class II and gives the reason as "Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration". 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-1926-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-17
Posted: 2014-06-26
Terminated: 2014-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
Product code: JIT Calibrator, Secondary
Reason for recall: Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent an Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised immediate discontinuation of use and discard of the affected device. Please complete the attached Effectiveness Check form and fax it to the Siemens Customer Care Center at (302) 631-8467 to indicate that you have received this information. Also, please indicate any replacement product required. Please contact Siemens Customer Care Center- Technical Solutions at (800) 441 9250 if you are aware of any adverse event that occurred as a consequence of this issue, or for immediate product needs. Please retain this letter with your laboratory records, and forward this Jetter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 1625
Distribution: Distribution: US Nationwide including Puerto Rico
Product codes and lots: Lot Number - 3DD007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1926-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1926-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)