Z-3119-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- April 10, 2017
- Termination Date
- February 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 US
Product Description
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).
Reason for Recall
Some anomalies have been identified during manufacturing controls.
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.
Code Information
Serial Numbers - IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019