Biomerieux France Chemin De L'Or recalls ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochem

Recalled February 5, 2014 · FDA recall Z-0841-2014 · 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. · FDA Class II

Units

39439 kits (includes ZYM B reagents, API Listeria * API NH kits)

Sold at

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

Description

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.

Product

ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

Manufacturer(s)

Biomerieux France Chemin De L'Or

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →