Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0541-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Product Classification:

Class II

Date Initiated: September 18, 2013

Date Posted: December 25, 2013

Recall Number: Z-0541-2014

Event ID: 66363

Reason for Recall:

Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

Status: Terminated

Product Quantity: 302

Code Information:

lot 13064MA, expiration 2014-03-05

Distribution Pattern:

Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.

Voluntary or Mandated:

Voluntary: Firm initiated