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U.S. Department of Health and Human Services

Class 3 Device Recall ADVIA Centaur Cleaning Solution Concentrate

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  Class 3 Device Recall ADVIA Centaur Cleaning Solution Concentrate see related information
Date Initiated by Firm September 12, 2014
Date Posted November 14, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall Number Z-0214-2015
Recall Event ID 69282
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems)
Catalog Number: 112748
(Siemens Material Number (SMN): 10310041

The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
Code Information Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-668-5000
Manufacturer Reason
for Recall		 Stability of the ADVIA Centaur Cleaning Solution is not assured
FDA Determined
Cause 2		 Material/Component Contamination
Action Siemens issued an Urgent Medical Device Recall (UMDR) to customers in the US on September 12, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 12, 2014. These notices inform the customer of the degradation of hypochlorite in these lots of cleaning solution. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Fax-back forms will be used to confirm that the customers received the UMDR. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall For questions regarding this recall call 508-668-5000.
Quantity in Commerce 4645 (12 pk)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.
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.
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