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Recall Observatory FDA recall evidence

Device 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).

Z-3119-2017

April 10, 2017

Class II

Product summary

Firm
bioMerieux, Inc.
Event
Event 77989
Status
Terminated
Classification
Class II
Quantity
15 US
Official record key
device-enforcement:Z-3119-2017

Official wording

Reason: Some anomalies have been identified during manufacturing controls.

Code information: Serial Numbers - IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some anomalies have been identified during manufacturing controls.