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bioMerieux, Inc. recalls eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purificatio
Recalled September 20, 2017 · FDA recall Z-3119-2017 · bioMerieux
Hazard
Some anomalies have been identified during manufacturing controls. · FDA Class II
Units
15 US
Sold at
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.
Description
Some anomalies have been identified during manufacturing controls.
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).
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →