Recall Z-0430-2014— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0430-2014
Creator: U.S. Food and Drug Administration
Published: 2013-05-20

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-05-20, terminated 2014-04-10. It names one FDA 510(k) clearance: K051087. Product: Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.. Reason: There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-20
Terminated: 2014-04-10
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

Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.

Reason for recall

There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1

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