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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 Recall
MicroScan Dried Negative Breakpoint Combo
see related information
Date Posted June 08, 2013
Recall Status1 Terminated 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, California 95691-3427
Consumer Instructions Contact the recalling firm for information
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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