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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur Vitamin D Assay (100 tests)

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 Class 2 Device Recall Siemens ADVIA Centaur Vitamin D Assay (100 tests)see related information
Date Initiated by FirmMarch 13, 2013
Date PostedApril 15, 2013
Recall Status1 Terminated 3 on March 05, 2015
Recall NumberZ-1119-2013
Recall Event ID 64610
Product Classification System, test, vitamin d - Product Code MRG
ProductADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Code Information Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013  Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date:  92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013
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		Negative bias in patient samples for Vitamin D
FDA Determined
Cause 2		No Marketing Application
ActionSiemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.
Quantity in Commerce3871
DistributionNationwide Distribution.
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.
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