FDA-Device2014-02-05Class II
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.
Biomerieux France Chemin De L'Or
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe
Affected count
39439 kits (includes ZYM B reagents, API Listeria * API NH kits)
Manufactured in
Chemin De L'Orme, Marcy L'Etoile, France
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0843-2014Don't want to check this manually?
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