Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1926-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 17, 2013

Date Posted: July 2, 2014

Recall Number: Z-1926-2014

Event ID: 66364

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.

Status: Terminated

Product Quantity: 1625

Code Information:

Lot Number - 3DD007

Distribution Pattern:

Distribution: US Nationwide including Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated