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U.S. Department of Health and Human Services

Class 2 Device Recall eMAG System

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  Class 2 Device Recall eMAG System see related information
Date Initiated by Firm April 10, 2017
Create Date September 12, 2017
Recall Status1 Terminated 3 on February 24, 2022
Recall Number Z-3119-2017
Recall Event ID 77989
Product Classification Clinical sample concentrator - Product Code JJH
Product eMAG System, Ref 418591

It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
Code Information Serial Numbers - IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Tiffany Mentzel
919-620-3396
Manufacturer Reason
for Recall		 Some anomalies have been identified during manufacturing controls.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The firm, Biomerieux, sent an "IMPORTANT: URGENT PRODUCT SAFETY CORRECTION NOTICE" letter on 4/10/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees were instructed to distribute this information to all appropriate personnel; retain copy for files; forward information to all parties that may use this product; perform a Main Board Re-initialization after each weekly maintenance; and complete and return the Acknowledgment Form by Fax to + 33 (0) 04 78 87 73 07 to confirm receipt of notice. A Field Service engineer will come on site to check the unit. If you require additional assistance or have any questions, please contact your local bioM¿rieux Customer Service representative or call 919-620-3396 or email: tiffiany.mentzel@biomerieux.com.
Quantity in Commerce 15 US
Distribution Worldwide Distribution: US (nationwide) to states of: GA, IL, IN, MA, NC & TX and to countries of: Austria, France, Germany, Hong Kong, Italy, Netherlands, Spain, Sweden, Switzerland, Thailand and United Kingdom.
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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