Recall Z-1316-2014— Siemens Medical Solutions Diagnostics

Name: FDA recall Z-1316-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-03

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions Diagnostics, initiated 2014-02-03, terminated 2016-06-30. It names one FDA 510(k) clearance: K970227. Product: IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000. Reason: There is a potential for incorrect results to be reported from processing of a sample tube..

Recalling firm: Siemens Medical Solutions Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2014-02-03
Terminated: 2016-06-30
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

IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

Reason for recall

There is a potential for incorrect results to be reported from processing of a sample tube.

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