BACTERIA COMBINATION (Adenosinum Triphosphoricum Dinatrum, Malic Acid, Natrum Oxalaceticum, Oroticum Acidum, Riboflavinum, Apiolum, Cinnamic Acid, Streptococcus Viridans, Pneumococcinum, Colibacillinum Cum Natrum Muriaticum, Echinacea (Angustifolia), Helicobacter Pylori, Mycoplasma Pneumoniae, Proteus (Mirabilis), Proteus (Vulgaris), Pseudomonas Aeruginosa, Yersinia Enterocolitica, Streptococcus Agalactiae, Legionella Pneumophila, Enterococcus Faecalis, Streptococcus Mutans, Listeria Monocytogenes, Dysentery Bacillus,) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jun 4, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 4, 2019 Category: Drugs & Pharmacology Source Type: alerts

BACTERIA COMBINATION (Atp (Adenosine Triphosphate Disodium), Malic Acid, Natrum Oxalaceticum, Oroticum Acidum, Riboflavinum, Apiolum, Cinnamic Acid, Streptococcus Viridans, Colibacillinum Cum Natrum Muriaticum, Echinacea, Helicobacter Pylori, Mycoplasma Pneumoniae, Proteus (Mirabilis), Proteus (Vulgaris), Pseudomonas Aeruginosa, Streptococcus Pneumoniae, Yersinia Enterocolitica, Streptococcus Agalactiae, Legionella Pneumophila, Enterococcus Faecalis, Streptococcus Mutans, Listeria Monocytogenes, Dysentery Bacillus,) Liquid [Deseret Biologicals, Inc.]
Updated Date: Oct 31, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 31, 2018 Category: Drugs & Pharmacology Source Type: alerts

bioMerieux, Inc. - VITEK(R) 2 ASTP640 - Class 2 Recall
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted ...
Source: Medical Device Recalls - September 16, 2018 Category: Medical Devices Source Type: alerts

bioMerieux, Inc. - VITEK(R) 2 ASTP655 - Class 2 Recall
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted ...
Source: Medical Device Recalls - September 16, 2018 Category: Medical Devices Source Type: alerts

BioMerieux SA - Class 2 Recall
The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the 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. Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine t...
Source: Medical Device Recalls - June 13, 2018 Category: Medical Devices Source Type: alerts

BioMerieux SA - ETEST - Class 2 Recall
ETEST¿ OXACILLIN OX 256 WW F100 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. Curren...
Source: Medical Device Recalls - December 20, 2017 Category: Medical Devices Source Type: alerts

BioMerieux SA - ETEST - Class 2 Recall
ETEST¿ OXACILLIN OX 256 US F100 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. Curre...
Source: Medical Device Recalls - December 20, 2017 Category: Medical Devices Source Type: alerts

MOGUT (Lactobacillus Fermentum, Lactobacillus Sakei, Leuconostoc Holzapfelii, Leuconostoc Mesenteroides, Enterococcus Faecium) Liquid [COENBIO CO., LTD.]
Updated Date: Sep 5, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 5, 2017 Category: Drugs & Pharmacology Source Type: alerts

UPPER RESPIRATORY STAPH/STREP COMBINATION (Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans) Tablet [Deseret Biologicals, Inc.]
Updated Date: Jun 1, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 1, 2017 Category: Drugs & Pharmacology Source Type: alerts

BioMerieux SA - ETEST Benzyl Penicillin - Class 2 Recall
ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). 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...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

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

BioMerieux SA - ETEST Ceftazidime - Class 2 Recall
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 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...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Fosfomycin - Class 2 Recall
ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. 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 Cephalotin - Class 2 Recall
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...
Source: Medical Device Recalls - March 22, 2017 Category: Medical Equipment Source Type: alerts

BioMerieux SA - ETEST Ceftriaxone - Class 2 Recall
ETEST¿ Ceftriaxone TXL32 SPB, 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