Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0253-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 3, 2012

Date Posted: November 14, 2012

Recall Number: Z-0253-2013

Event ID: 62833

Reason for Recall:

Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.

Status: Terminated

Product Quantity: 583 cartons

Code Information:

Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012

Distribution Pattern:

USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated