Home / Recalls / Biomerieux France Chemin De L'Or / Z-0841-2014

Z-0841-2014 Class II Terminated

Recalled by Biomerieux France Chemin De L'Or — Marcy L'Etoile

FDA device recall Z-0841-2014 was initiated by Biomerieux France Chemin De L'Or on November 8, 2013 and is designated Class II. 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. The recall status is terminated (terminated November 30, 2017). Affected quantity: 39439 kits (includes ZYM B reagents, API Listeria * API NH kits).

Recall Details

Product Type: Devices
Report Date: February 5, 2014
Initiation Date: November 8, 2013
Termination Date: November 30, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 39439 kits (includes ZYM B reagents, API Listeria * API NH kits)

Product Description

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.

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.

Distribution Pattern

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

Code Information

Lot numbers: 1002171010, 1002295110, 1002360360, 1002421440, 1002485410, 1001951820, 1002011320, and 1002071020.