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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur XP Immunoassay System

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 Class 2 Device Recall ADVIA Centaur XP Immunoassay Systemsee related information
Date Initiated by FirmOctober 09, 2014
Date PostedDecember 23, 2014
Recall Status1 Terminated 3 on March 16, 2017
Recall NumberZ-0860-2015
Recall Event ID 69582
510(K)NumberK041133 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Code Information Product Codes: 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696 and 10471899. 
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
FDA Determined
Cause 2
Nonconforming Material/Component
ActionA slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Quantity in Commerce10,515 units total
DistributionNationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
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