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).
FDA Recall Z-3119-2017 · Posted None
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Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeJJH
Date Initiated2017-04-10
Date Terminated2022-02-24
Product Quantity15 US
Reason for Recall
Some anomalies have been identified during manufacturing controls.
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 bioMrieux Customer Service representative or call 919-620-3396 or email: [email protected].
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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