Z-3119-2017Class II

eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation...

Name: Z-3119-2017 eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation...
Creator: bioMerieux, Inc.
Published: 2017-04-10
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-04-10 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic... on 2017-04-10. FDA classified it as Class II and gives the reason as "Some anomalies have been identified during manufacturing controls". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3119-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Posted: 2017-09-12
Terminated: 2022-02-24
Recalling firm: bioMerieux, Inc.
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).
Product code: JJH Clinical Sample Concentrator
Reason for recall: Some anomalies have been identified during manufacturing controls.
Root cause tag: manufacturing process
FDA root cause: 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 bioMrieux Customer Service representative or call 919-620-3396 or email: [email protected].
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.
Product codes and lots: Serial Numbers - IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3119-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3119-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)