128 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·December 15, 2016
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Recall
Terminated
·Biomerieux 69280 Marcy Letoile France·Product code JWY·November 19, 2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Recall
Terminated
·Beckman Coulter, Inc.·Product code JWY·August 8, 2014
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Recall
Terminated
·Beckman Coulter, Inc.·Product code JWY·August 8, 2014
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Recall
Terminated
·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JWY·July 28, 2014
Etest Ceftaroline (CPT32) WWB100. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Recall
Terminated
·Biomerieux 69280 Marcy Letoile France·Product code JWY·October 16, 2014
Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Recall
Terminated
·Biomerieux 69280 Marcy Letoile France·Product code JWY·October 16, 2014
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Recall
Terminated
·Beckman Coulter, Inc.·Product code JWY·August 8, 2014
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·April 25, 2017
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
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·December 15, 2016
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·April 13, 2017
ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·April 13, 2017
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Enterococcus Screen Agar QUAD Plate
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JWY·June 29, 2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Recall
Terminated
·Beckman Coulter, Inc.·Product code JWY·August 8, 2014
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(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
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·December 15, 2016