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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Dried Negative Breakpoint Combo

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  Class 2 Device Recall MicroScan Dried Negative Breakpoint Combo see related information
Date Initiated by Firm May 02, 2013
Date Posting Updated June 08, 2013
Recall Status1 Terminated 3 on September 17, 2013
Recall Number Z-1525-2013
Recall Event ID 65188
Product Classification Panels, test, susceptibility, antimicrobial - Product Code LTT
Product Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099),

For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Code Information Lot: 2013-11-13, Exp 11/13/2013.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact Leslie Ardizone
916-374-3075
Manufacturer Reason
for Recall
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Siemens sent an Urgent Field Safety Notice dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Siemens Healthcare Diagnostics Representative for information concerning this notice.
Quantity in Commerce 683 units
Distribution Nationwide Distribution.
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.
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