Events

Recall of Device Recall ETEST Tobramycin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioMerieux SA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76201
  • Event Risk Class
    Class 2
  • Event Number
    Z-1531-2017
  • Event Initiated Date
    2016-12-15
  • Event Date Posted
    2017-03-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152514
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Reason
    Product stability issues: the current shelf-life claims of the etest products are not supported by internal testing.
  • Action
    biomerieux sent an Urgent Field Safety Notice dated December 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify the affected lots and immediately order the replacement products. Laboratories should continue to follow their current QC procedures. When replacement product is received, consignees should discontinue using any discard affected product. Consignees should distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward the information to all parties that may use this product, including others to whom they may have transferred our product. Consignees should contact their bioMerieux representative for product compensation. Consignees should also complete and return the Acknowledgment Form in Attachment A by Fax to confirm receipt of the notice. Consignees with questions should contact their local bioMerieux Clinical Customer Service representative. For questions regarding this recall call 314-731-8516.

Device

Device Recall ETEST Tobramycin
  • Model / Serial
    Reference no. 522718, Lot #1001761650, 1002112440, 1002860460 & 1005166530 and Reference no. 522758, Lot #1001888970, 1002281590 & 1003590490.
  • Product Classification
    Immunology and Microbiology Devices
  • 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 Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). || 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
    BioMerieux SA

Manufacturer

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