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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Folate

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  Class 2 Device Recall ADVIA Centaur Folate see related information
Date Initiated by Firm July 25, 2013
Date Posted September 10, 2013
Recall Status1 Terminated 3 on June 12, 2015
Recall Number Z-2169-2013
Recall Event ID 65806
510(K)Number K010050  
Product Classification Acid, folic, radioimmunoassay - Product Code CGN
Product ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974

In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Code Information 22288218, 22296218, 222907218
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		 Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
FDA Determined
Cause 2		 Material/Component Contamination
Action Siemens sent an Urgent Medical Device Correction letter on July 26, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. an Urgent Field Safety Notice was sent to all domestic customers via Federal Express. On July 25, 2013 this notice was sent to all OUS customers via hard copy, email, and/or fax as determined by each country's local regulations and procedures. These notices inform the customer that a portion of Folate ReadyPacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (QC) and patient results. If customers have an alternate lot of the ADVIA Centaur or ADVIA Centaur CP Folate assay, they are instructed that this lot should be used for future testing. However if no alternative lot is available, quality control (QC) results should be obtained for each individual ReadyPack as a QC or calibration is an indication of an affected pack. An affected pack must be replaced with a different Folate ReadyPack where a valid calibration and acceptable QC values are obtained. These notices should be reviewed by the facility's laboratory or medical director, though no look back is required. Customers were instructed that Fedex Return Receipts will be used to confirm that the customers received the UMDC. Customers with questions were instructed to contact their local Technical Support Provider or Distributor. For questions regarding this recall call 508-668-5000.
Quantity in Commerce 3114
Distribution Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
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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