Recall Z-0851-2014— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0851-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-07

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-10-07, terminated 2014-08-27. It names one FDA 510(k) clearance: K051087. Product: 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Terminated: 2014-08-27
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K051087 — DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc.·cleared 2005-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.