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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1477-2014

API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

Publicado el 30 de abril de 2014 · Inicio del retiro: 6 de marzo de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
BioMerieux SA
Distribuidor
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Lote
Code - 1002786740, Exp. Date 6/3/2014, 1002809140, Exp. Date 6/18/2014, 1002814890, Exp. Date 9/9/2014, 1002814891, Exp. Date 9/9/2014, 1002826750, Exp. Date 6/3/2014, 1002869720, Exp. Date 6/18/2014, 1002869721, Exp. Date 12/13/2014, 1002485910, Exp. Date 6/3/2014, 1002485911, Exp. Date 6/18/2014
Clasificación de riesgo
Class II
Área (FDA)
device
País
France

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