Device Recall FB Reagent (REF 70562)

  • Model / Serial
    Codes - 1002717180, Exp. Date 5/30/2014, 1002737220, Exp. Date 6/13/2014, 1002778550, Exp. Date 8/9/2014, 1002782960, Exp. Date 8/15/2014, 1002792840, Exp. Date 8/15/2014, 1002834130, Exp. Date 8/22/2014, 1002877370, Exp. Date 8/22/2014
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    FB Reagent (REF 70562). || FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
  • Source
    USFDA