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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur

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  Class 2 Device Recall ADVIA Centaur see related information
Date Initiated by Firm October 09, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on March 16, 2017
Recall Number Z-0859-2015
Recall Event ID 69582
510(K)Number K041133  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ADVIA Centaur (including refurbished)

Professional use in a laboratory for in vitro diagnostic tests.
Code Information Product Codes: 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011 and 10361012 
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
Action A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Quantity in Commerce 10,515 units total
Distribution Nationwide 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 Cycle TPLC 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) Database 510(K)s with Product Code = JJE and Original Applicant = BAYER HEALTHCARE, LLC
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