Recall Z-1553-2014— Siemens Healthcare Diagnostics

Name: FDA recall Z-1553-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-18

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2014-02-18, terminated 2017-03-06. It names one FDA 510(k) clearance: K971418. Product: ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.. Reason: Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling..

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Terminated: 2017-03-06
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K971418 — CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZERChiron Diagnostics Corp.·cleared 1997-07-17

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

ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.

Reason for recall

Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.

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