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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Neg Breakpoint Combo 34

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  Class 2 Device Recall MicroScan Neg Breakpoint Combo 34 see related information
Date Initiated by Firm May 14, 2014
Date Posted April 26, 2015
Recall Status1 Terminated 3 on April 27, 2015
Recall Number Z-1522-2015
Recall Event ID 70874
510(K)Number K862140  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product MicroScan -Neg Breakpoint Combo Panel Type 34;
Catalog number B1017-404; Panel
MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to
No.1 the species level of colonies, grown 34 on solid media, of rapidly growing
aerobic and facultative anaerobic gram-positive bacteria
Code Information Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact Jose Untalan
916-374-3031
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
FDA Determined
Cause 2		 Equipment maintenance
Action Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031
Quantity in Commerce 681 boxes
Distribution Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.
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 = JWY and Original Applicant = AMERICAN MICRO SCAN
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