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
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
Some anomalies have been identified during manufacturing controls.