Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0851-2014)

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:

User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

Product Classification:

Class II

Date Initiated: October 7, 2013

Date Posted: February 5, 2014

Recall Number: Z-0851-2014

Event ID: 66585

Reason for Recall:

When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.

Status: Terminated

Product Quantity: 2038

Code Information:

Material numbers 10284473, 10488224, 10444801, and 10444802.

Distribution Pattern:

USA (nationwide) Distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated