BioMerieux SA - ETEST Tobramycin - Class 2 Recall
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 a...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Ciprofloxacin - Class 2 Recall
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. 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 me...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Ceftriaxone - Class 2 Recall
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 ...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Doripenem - Class 2 Recall
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. 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 med...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Gentamicin - Class 2 Recall
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 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 a...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Imipenem - Class 2 Recall
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. 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 u...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Cefuroxime - Class 2 Recall
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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2017 Category: Medical Equipment Source Type: alerts

UPPER RESPIRATORY STAPH STREP COMBINATION (Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jan 12, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 12, 2017 Category: Drugs & Pharmacology Source Type: alerts

STREPTOCOCCUS HOMOCHORD (Enterococcus Faecalis, Pheumococcinum, Streptococcus Viridans, Streptococcus Mutans) Liquid [Deseret Biologicals, Inc.]
Updated Date: Sep 30, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 30, 2016 Category: Drugs & Pharmacology Source Type: alerts

UPPER RESPIRATORY STAPH STREP COMBINATION (Staphylococcus Aureus, Klebsiella Pheumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jul 26, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 26, 2016 Category: Drugs & Pharmacology Source Type: alerts

Biomerieux Inc - VITEK 2 Gram Positive Susceptibility Test Cards - Class 1 Recall
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Biomerieux Inc - VITEK 2 Gram Positive Susceptibility Test Cards - Class 1 Recall
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Biomerieux Inc - VITEK 2 Gram Positive Susceptibility Test Cards - Class 1 Recall
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Biomerieux Inc - VITEK 2 Gram Positive Susceptibility Test Cards - Class 1 Recall
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts

Biomerieux Inc - VITEK 2 Gram Positive Susceptibility Test Cards - Class 1 Recall
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts