| Class 2 Device Recall ADVIA Centaur XP Immunoassay System | |
Date Initiated by Firm | October 09, 2014 |
Date Posted | December 23, 2014 |
Recall Status1 |
Terminated 3 on March 16, 2017 |
Recall Number | Z-0860-2015 |
Recall Event ID |
69582 |
510(K)Number | K041133 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | ADVIA 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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJE
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