bioMerieux, Inc. recalls eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification…

Recall date

April 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3119-2017

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

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.

Why it was recalled

Some anomalies have been identified during manufacturing controls.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).