Device Recall ETEST Vancomycin

  • Model / Serial
    Reference no. 525550, Lot #1001094650, 1001136230, 1001212920, 1001293800, 1001302920, 1001319720, 1001334090, 1001391310, 1001430030, 1001518060 & 1001686190; Reference no. 525558, Lot #1001174720, 1001251340, 1001334100, 1001368020, 1001442000, 1001566840, 1001647970, 1001734920, 1001761450, 1001761480, 1001897000, 1001898600, 1002008040, 1002073480, 1002197270, 1002282890, 1002338820, 1002365880, 1002443950, 1002465840, 1002558040, 1002562240, 1002733640, 1002751340, 1003171920, 1003449250, 1003679000, 1003836080, 1004040220, 1004121870, 1004151340, 1004173130, 1004256780, 1004264340, 1004371500, 1004491190, 1004509340, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320, 1005186480, 1004735790, 1004767430, 1004775900, 1004914010, 1004980280, 1005027180 & 1005132340; Reference no. 525510, Lot #1001051200, 1001125840, 1001416930, 1001455150, 1001548250 & 1001596090 and Reference no. 525518, Lot #1001192860, 1001223460, 1001317000, 1001338170, 1001416940, 1001416950, 1001492590, 1001566860, 1001634070, 1001728340, 1001761460, 1001887350, 1001894800, 1002007990, 1002045080, 1002113290, 1002197250, 1002287970, 1002338070, 1002369060, 1002440920, 1002463490, 1002496690, 1002565090, 1002583690, 1002604690, 1002663860, 1002809200, 1002809880, 1002876470, 1002922750, 1003079740, 1003134480, 1003373510, 1003621540, 1003778630, 1003809630, 1003910700, 1003972790, 1004052410, 1004121860, 1004150380, 1004256770, 1004371490, 1004496990, 1004508060, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320 & 1005186480.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia
  • Product Description
    ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions
  • Manufacturer
  • 1 Event

Manufacturer

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