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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Myoglobin Calibrator

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  Class 2 Device Recall Dimension Vista Myoglobin Calibrator see related information
Date Initiated by Firm November 24, 2014
Date Posted January 08, 2015
Recall Status1 Terminated 3 on December 13, 2016
Recall Number Z-0946-2015
Recall Event ID 69937
510(K)Number K053576  
Product Classification Calibrator, secondary - Product Code JIT
Product Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085

Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
Code Information Lot 4FD085, exp. 12-01-2014
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Siemens, sent an "Urgent Medical Device Recall"letter dated November 2014, to all customers who received the affected lot. The letter described the product, problem and actions to be taken. The customers were instructed to: Review this letter with your Medical Director; discard your remaining inventory; recalibrate with an alternate in-date lot of MYO CAL, and complete and return the attached Field Correction Effectiveness Check Form and fax the form to (312) 275-7795. Siemens will replace any unused inventory of the affected lot at no charge. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at 800-441-9250 or your local Siemens technical support representative.
Quantity in Commerce 1230
Distribution Worldwide Distribution: US (nationwide) and country of: Canada.
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 = JIT and Original Applicant = DADE BEHRING, INC.
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