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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent

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  Class 2 Device Recall ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent see related information
Date Initiated by Firm July 27, 2015
Date Posted September 04, 2015
Recall Status1 Terminated 3 on February 26, 2016
Recall Number Z-2739-2015
Recall Event ID 71843
510(K)Number K010050  
Product Classification Acid, folic, radioimmunoassay - Product Code CGN
Product ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877.
Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Code Information Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
877-229-3711
Manufacturer Reason
for Recall		 Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
FDA Determined
Cause 2		 Process design
Action An Urgent Medical Device Recall (UMDR) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 27, 2015 to be delivered to customers on July 28, 2015. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 27, 2015. These notices inform the customer to discontinue use of ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent kit lots 54942, 56230 and 70673 and dispose of the remaining inventory per local regulations. The ADVIA Centaur Systems Folate red blood cell sample and control negative bias is minimal in the lower range of the assay and is more pronounced with increasing folate concentrations. The negative bias could lead to a misclassification of a patient as folate deficient. Siemens does not recommend a look back of previously tested patients. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall. 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 and completed the required actions.
Quantity in Commerce 466
Distribution Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
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 = CGN and Original Applicant = BAYER DIAGNOSTICS CORP.
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