Recall Z-3119-2017— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2017-04-10, terminated 2022-02-24. FDA's recall record names no specific 510(k) clearance for this event. 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 characteristics or after pre-treatment).. Reason: Some anomalies have been identified during manufacturing controls..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-10
- Terminated
- 2022-02-24
- Firm location
- Durham, NC, United States
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).
Reason for recall
Some anomalies have been identified during manufacturing controls.
Data sourced from openFDA. This site is unofficial and independent of the FDA.