Food, drugs, devices › bioMerieux, Inc.
Device recall: eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification a
FDA enforcement event 77989 is a device recall by bioMerieux, Inc. of Durham, NC, initiated 10 Apr 2017 and classified Class II, with 1 product record.
FDA defines Class II as 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 24 Feb 2022. Initiation: voluntary: firm initiated. bioMerieux, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
bioMerieux, Inc., Durham, NC.
Reason for recall
"Some anomalies have been identified during manufacturing controls."
Distribution
"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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3119-2017 | 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). | 15 US | Class II | Terminated | 20 Sep 2017 |
Context
Other enforcement events for bioMerieux, Inc.
All 57 events for bioMerieux, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Some anomalies have been identified during manufacturing controls."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Feb 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.