Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3119-2017·Announced 2017-09-20

bioMerieux Recalls eMAG System Due to Manufacturing Anomalies

bioMerieux, Inc. is recalling 15 eMAG System units in the US and 11 countries due to anomalies identified during manufacturing controls.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or specific functional failures, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

bioMerieux, Inc. is voluntarily recalling 15 units of the eMAG System, Reference 418591. This in vitro diagnostic medical device is intended for the automated isolation, purification, and concentration of total nucleic acids (RNA/DNA) from biological specimens. The recall is being conducted because anomalies were identified during manufacturing controls.

The affected units are distributed nationwide in the United States, specifically in Georgia, Illinois, Indiana, Massachusetts, North Carolina, and Texas. The devices are also distributed in Austria, France, Germany, Hong Kong, Italy, the Netherlands, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. The specific serial numbers for the recalled units are IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, and IM03019.

Healthcare facilities and users should check their inventory for these specific serial numbers. If the eMAG System is found, it should be removed from service and returned to bioMerieux, Inc. for further instructions.

The recalled product

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…
Manufacturer: bioMerieux, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: manufacturing-anomaly
Affected units: 15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

Serial Numbers - IM03001
IM03002
IM3004
IM03005
IM03006
IM03007
IM03008
IM03009
IM03011
IM03012
IM03013
IM03014
IM03015
IM03017
IM03019

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · bioMerieux, Inc.

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