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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur XP Immunoassay

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 Class 2 Recall
ADVIA Centaur XP Immunoassay
see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1553-2014
Recall Event ID 67603
Premarket Notification
510(K) Numbers
K041133  K971418 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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.
Code Information All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown, New York 10591-5005
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action On February 18, 2014 Siemens Healthcare Diagnostics distributed Urgent Medical Device Correction notices to their customers via courier service (Urgent Medical Device Correction/). Upon receipt of the communication, customers are asked to follow "Actions to be Taken by the Customer". If the cover is unable to stay partially raised, immediately contact your Siemens technical support representative to arrange for a service. Complete and return the Field Correction Effectiveness Check attached to this letter within thirty (30) days by faxing to (302) 631-7597. Customers with questions should contact their Siemens technical support representative.
Quantity in Commerce 5,900 units total (1,679 domestically & 4,221 internationally)
Distribution Nationwide and internationally
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BAYER HEALTHCARE, LLC
510(K)s with Product Code = JJE and Original Applicant = CHIRON DIAGNOSTICS CORP.
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