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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

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.
Recall Number Z-1553-2014
Classification Class II
Code Info All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Product Distributed Qty 5,900 units total (1,679 domestically & 4,221 internationally)
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.

Event Detail

Event Id 67603
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics
City Tarrytown
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and internationally