128 results
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11ms
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Sources: EU EUDAMED, US FDA
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MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JWY·June 16, 2011
MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101
FDA Recall
Terminated
·Siemens Microscan·Product code JWY·July 31, 2008
BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JWY·June 6, 2013
Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW 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
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. 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
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
Etest Ceftaroline (CPT32) US B100. 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
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JWY·March 26, 2018
Etest PIP/TAZO/CON-4 PTC 256 -pack of 30 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
Etest Ceftaroline (CPT32) WW 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
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·January 1, 2017
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. Siemens Healthcare Diagnostics, West Sacramento, CA. For use in determining quantitative and / or qualitative antimicrobial agent susceptibility and / or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JWY·June 16, 2011
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JWY·June 16, 2011
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 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: ESL plus, Catalog B1027-101 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
Vancomycin Screen Agar
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JWY·June 29, 2015
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·January 18, 2017
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 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