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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Vitamin D Diluent 2pack

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  Class 2 Device Recall ADVIA Centaur Vitamin D Diluent 2pack see related information
Date Initiated by Firm February 16, 2012
Date Posted March 21, 2012
Recall Status1 Terminated 3 on October 17, 2013
Recall Number Z-1268-2012
Recall Event ID 61236
510(K)Number K110586  
Product Classification System, test, vitamin d - Product Code MRG
Product Siemens ADVIA Centaur Vitamin D Diluent 2-pack,
Reference 10494100
in vitro diagnostic use in the quantitative determination of total
25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems

The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay.
Code Information Lot # 80230 Expiry Date 04 May 2012
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		 Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Siemens Healthcare Diagnostics, sent an "Urgent Device Recall Notice" on February 16, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to discontinue using the automatic and system-performed dilution features for Vitamin D; to discontinue the use of ADVIA Centaur VitD Diluent, 2-pack (REF 10494100); to manually dilute samples with values greater than the assay range of 150 ng/mL (375 nmoI/L), using the ADVIA Centaur VitD Diluent, 1 bottle (REF 10632114) as stated in the Vitamin D assay Instructions For Use (IFU); to review the contents of the recall notice with their Laboratory Director and retest the previous sample results generated using system- performed dilutions, and complete and return the confirmation fax-back form via fax to TECHNICAL SOLUTIONS CENTER at (302) 631-7597. If you have any questions or need additional information, please contact your local Technical Support Provider or Distributor or call (508) 668-5000.
Quantity in Commerce 442 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Columbia, China, Denmark, Egypt, and Hong Kong.
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 = MRG and Original Applicant = Siemens Healthcare Diagnostics Inc.
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