bioMerieux, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3119-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: April 10, 2017

Date Posted: September 20, 2017

Recall Number: Z-3119-2017

Event ID: 77989

Reason for Recall:

Some anomalies have been identified during manufacturing controls.

Status: Terminated

Product Quantity: 15 US

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated