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U.S. Department of Health and Human Services

Class 1 Device Recall MicroScan Synergies plus Panels &38; MicroScan Rapids plus (Negative)

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  Class 1 Device Recall MicroScan Synergies plus Panels &38; MicroScan Rapids plus (Negative) see related information
Date Initiated by Firm August 21, 2013
Date Posted September 11, 2013
Recall Status1 Terminated 3 on May 15, 2014
Recall Number Z-2123-2013
Recall Event ID 66058
510(K)Number K020246  K020249  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product Microscan Synergies Plus Negative Urine Combo 5


Product Usage:
MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Code Information Internal Number - B1025-115; Catalog Number - 10483101 Lot code/expiration date: 2012-09-22, 2012-09-22; 2013-01-20, 2013-01-20; 2013-05-07, 2013-05-07; 2013-11-01, 2013-11-01; 2014-03-05, 2014-03-05. 
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		 Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
FDA Determined
Cause 2		 Process control
Action Siemens sent an Urgent Field Safety Notice letters dated August 2013 to all US customers via over night delivery, receipt requested. Letters for foreign customers are being translated and will be sent as soon as possible. The letter identified the affected product, reason for field correction, risk to health problem and actions to be taken by customer. Customers were instructed to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that the customer consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. Customer were requested to complete the attached Field Correction Effectiveness Check form and fax it to 302-631-8467. For questions contact your Siemens Technical Support Provider or Distributor.
Quantity in Commerce 522 boxes, 10, 440 panels
Distribution Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.
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 = LON and Original Applicant = DADE BEHRING, INC.
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