Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0818-2014)

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:

Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.

Product Classification:

Class II

Date Initiated: December 5, 2013

Date Posted: January 29, 2014

Recall Number: Z-0818-2014

Event ID: 67057

Reason for Recall:

Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.

Status: Terminated

Product Quantity: 1586

Code Information:

lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated