Reported Sep 20, 2017 · Terminated

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

bioMerieux, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402

Is this the product you have?

  • 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).
Lot codes and dates
    • Serial Numbers - IM03001
    • IM03002
    • IM3004
    • IM03005
    • IM03006
    • IM03007
    • IM03008
    • IM03009
    • IM03011
    • IM03012
    • IM03013
    • IM03014
    • IM03015
    • IM03017
    • IM03019
Amount recalled
15 US

Where it was sold

Why it was recalled

Some anomalies have been identified during manufacturing controls.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 24, 2022 · Data as of Sep 19, 6:16 PM UTC

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