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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista beta2Microglobulin Flex Reagent Cartridge (B2MIC)

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  Class 2 Device Recall Dimension Vista beta2Microglobulin Flex Reagent Cartridge (B2MIC) see related information
Date Initiated by Firm July 23, 2015
Date Posted August 22, 2015
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-2450-2015
Recall Event ID 71831
510(K)Number K083463  
Product Classification System, test, beta-2-microglobulin immunological - Product Code JZG
Product Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC);

Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Code Information Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13;  Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26 
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		 customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.
FDA Determined
Cause 2		 Environmental control
Action Siemens sent an Urgent Medical Device Correction letter dated July 2015 to all affected customers. The letter identified the affected product, problem, risk to health, and actions to be taken by customers. For questions contact your Customer Care Center - Technical Solutions at 1-800-441-9250 or your local Siemens technical support representative.
Quantity in Commerce Total 1655 units
Distribution US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI
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 = JZG and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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