Recall Z-1832-2014— Siemens Medical Solutions Diagnostics

Name: FDA recall Z-1832-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-25

Class III · Terminated

Class III FDA medical device recall by Siemens Medical Solutions Diagnostics, initiated 2014-04-25, terminated 2015-04-16. It names one FDA 510(k) clearance: K970227. Product: VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.. Reason: The keyboard and monitor may not be properly secured to the monitor arm..

Recalling firm: Siemens Medical Solutions Diagnostics
Classification: Class III
Status: Terminated
Initiated: 2014-04-25
Terminated: 2015-04-16
Firm location: Flanders, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K970227 — IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERDpc Cirrus·cleared 1997-04-08

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

VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.

Reason for recall

The keyboard and monitor may not be properly secured to the monitor arm.

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