Recall Z-0843-2014— Biomerieux France Chemin De L'Or
Class II · Terminated
Class II FDA medical device recall by Biomerieux France Chemin De L'Or, initiated 2013-11-08, terminated 2017-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.. Reason: bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent..
- Recalling firm
- Biomerieux France Chemin De L'Or
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-08
- Terminated
- 2017-11-30
- Firm location
- Marcy L'Etoile, France
Product description
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
Reason for recall
bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.
Data sourced from openFDA. This site is unofficial and independent of the FDA.