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BIOMERIEUX INC

VITEK 2 · Chemistry

510(k): 56 Recall: 10 UDI: 0 MAUDE: 10 Class.: 67

510(k) Clearances (56)

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
2024-06-12

Substantially Equivalent

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
2024-06-07

Substantially Equivalent

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
2024-03-11

Substantially Equivalent

VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
2023-06-26

Substantially Equivalent

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
2023-02-09

Substantially Equivalent

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
2023-01-27

Substantially Equivalent

VITEK 2 AST-Gram Positive Cefoxitin Screen
2022-10-13

Substantially Equivalent

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
2022-07-12

Substantially Equivalent

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
2022-04-14

Substantially Equivalent

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
2022-02-25

Substantially Equivalent

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
2021-10-28

Substantially Equivalent

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
2021-08-30

Substantially Equivalent

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
2021-07-09

Substantially Equivalent

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
2021-06-14

Substantially Equivalent

VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
2020-09-28

Substantially Equivalent

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
2020-03-13

Substantially Equivalent

VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
2019-08-05

Substantially Equivalent

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
2019-06-06

Substantially Equivalent

VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
2019-03-07

Substantially Equivalent

VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
2019-02-26

Substantially Equivalent

VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
2019-02-20

Substantially Equivalent

VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
2017-12-08

Substantially Equivalent

VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
2017-06-21

Substantially Equivalent

VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
2017-02-16

Substantially Equivalent

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)
2017-02-01

Substantially Equivalent

VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
2017-01-12

Substantially Equivalent

VITEK 2 AST - YEAST FLUCONAZOLE
2014-08-05

Substantially Equivalent

VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
2013-09-13

Substantially Equivalent

VITEK 2 AST STREPTOCOCUS VANCOMYCIN
2012-11-19

Substantially Equivalent

VITEK 2 STRPTOCOCCUS CEFTRIAXONE
2012-08-28

Substantially Equivalent

VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
2012-06-29

Substantially Equivalent

VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
2011-11-30

Substantially Equivalent

VITEK 2 STREPTOCOCCUS PENICILLIN
2011-10-26

Substantially Equivalent

VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
2011-10-18

Substantially Equivalent

VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
2011-10-14

Substantially Equivalent

VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
2011-10-03

Substantially Equivalent

VITEK 2 STRPTOCOCCUS AMPICILLIN
2011-09-15

Substantially Equivalent

VITEK 2 YEAST CASPOFUNGIN
2010-09-28

Substantially Equivalent

VITEK 2 GRAM POSITIVE DAPTOMYCIN
2009-06-18

Substantially Equivalent

VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
2008-04-30

Substantially Equivalent

VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
2008-02-28

Substantially Equivalent

VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
2008-01-23

Substantially Equivalent

VITEK 2 GRAM NEGATIVE PIPERACILLIN
2007-12-10

Substantially Equivalent

VITEK 2 GRAM POSITIVE TIGECYCLINE
2007-11-16

Substantially Equivalent

VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
2007-01-11

Substantially Equivalent

VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
2006-12-21

Substantially Equivalent

VITEK 2 AST-YS FLUCONAZOLE
2006-09-19

Substantially Equivalent

VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
2005-12-01

Substantially Equivalent

VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
2005-08-16

Substantially Equivalent

VITEK 2 GRAM POSITIVE MEROPENEM
2005-05-12

Substantially Equivalent

VITEK 2 ESBL TEST
2004-06-08

Substantially Equivalent

VITEK 2 GRAM NEGATIVE GATIFLOXACIN
2003-11-04

Substantially Equivalent

VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
2003-10-31

Substantially Equivalent

VITEK 2 GRAM POSITIVE GATIFLOXACIN
2003-08-22

Substantially Equivalent

VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
2003-08-13

Substantially Equivalent

VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
2002-03-25

Substantially Equivalent

Recalls (10)

VITEK 2 Gram Negative Susceptibility Card, AST-GN22, REF 22 227, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN23, REF 22 228, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN24, REF 22 229, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN25, REF 22 230, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN26, REF 22 244, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN27, REF 22 245, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN28, REF 22 254, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN29, REF 22 266, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN30, REF 22 267, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

VITEK 2 Gram Negative Susceptibility Card, AST-GN31, REF 22 268, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
2010-09-16

AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.

MAUDE Adverse Events (10)

Malfunction
20080226
Malfunction
Malfunction
Malfunction
Malfunction
Malfunction
Malfunction
Malfunction
Malfunction
Malfunction

FDA Classification (67)

Mixer, Blood Tube

Clinical Chemistry

Bromcresol Green Dye-Binding, Albumin

Clinical Chemistry

Acid Phosphatase, Disodium Phenylphosphate

Clinical Chemistry

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Clinical Chemistry

Chromatography Separation/Zimmerman 17-Ketogenic Steroids

Clinical Chemistry

Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Clinical Chemistry

Conversion To Creatinine, Creatine

Clinical Chemistry

Electrode, Ion Specific, Urea Nitrogen

Clinical Chemistry

Breast Milk Macronutrients Test System

Clinical Chemistry

Acid, Ferric Ion-Sulfuric, Cholesterol

Clinical Chemistry

Fluorometric Method, Triglycerides

Clinical Chemistry

Prognostic Test For Development Or Progression Of Preeclampsia

Clinical Chemistry

Fluorometer, For Clinical Use

Clinical Chemistry

Spectrophotometric, Uroporphyrin

Clinical Chemistry

Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)

Clinical Chemistry

Fluorometric Method, 17-Hydroxycorticosteroids

Clinical Chemistry

Prescription Use Blood Glucose Meter For Near-Patient Testing

Clinical Chemistry

Droplet Digital Pcr System

Clinical Chemistry

Flame Emission Photometer For Clinical Use

Clinical Chemistry

Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes

Clinical Chemistry

Acid, Uric, Uricase (Colorimetric)

Clinical Chemistry

Acid, Lactic, Enzymatic Method

Clinical Chemistry

Indicator, Alumina Fluorescent, Tlc

Clinical Chemistry

Radioimmunoassay For Cyclosporine

Clinical Chemistry

Blood Collection Device For Cell-Free Nucleic Acid

Clinical Chemistry

Galectin-3 In Vitro Diagnostic Assay

Clinical Chemistry

Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline

Clinical Chemistry

Plate, Silica Gel, Tlc

Clinical Chemistry

Radioimmunoassay, C-Peptides Of Proinsulin

Clinical Chemistry

System, Breath Measurement

Clinical Chemistry

Radial Diffusion, Amylase

Clinical Chemistry

Radioimmunoassay, Cortisol

Clinical Chemistry

Chromatographic/Fluorometric Method, Catecholamines

Clinical Chemistry

Photometric Method, Ammonia

Clinical Chemistry

Insulin Pump Secondary Display

Clinical Chemistry

Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

Clinical Chemistry

Apolipoproteins

Clinical Chemistry

Radioimmunoassay, Thyroxine-Binding Globulin

Clinical Chemistry

Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase

Clinical Chemistry

Turbidimetric Method, Globulin

Clinical Chemistry

2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)

Clinical Chemistry

Cuvette, Thermostated

Clinical Chemistry

Turbidimetric, Total Protein

Clinical Chemistry

Vanillin Pyruvate, Ast/Sgot

Clinical Chemistry

Internal Polymerase Chain Reaction Control, Not Assay Specific

Clinical Chemistry

Ph Rate Measurement, Carbon-Dioxide

Clinical Chemistry

Cresolphthalein Complexone, Calcium

Clinical Chemistry

Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

Clinical Chemistry

Radioimmunoassay, Pregnenolone

Clinical Chemistry

Immunoassay Method, Troponin Subunit

Clinical Chemistry

Cyclosporine

Clinical Chemistry

Setmelanotide Eligibility Gene Variant Detection System

Clinical Chemistry

Unit, Filter, Membrane

Clinical Chemistry

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Clinical Chemistry

Shaker/Stirrer

Clinical Chemistry

Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Clinical Chemistry

Instrumentation, High Pressure Liquid Chromatography

Clinical Chemistry

Radioimmunoassay, Gastrin

Clinical Chemistry

Refractometer For Donor Testing

Clinical Chemistry

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Clinical Chemistry

Radioassay, Intrinsic Factor Blocking Antibody

Clinical Chemistry

Radioimmunoassay, Acth

Clinical Chemistry

Enzymatic Method, Bilirubin

Clinical Chemistry

L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

Clinical Chemistry

Automated Radioimmunoassay Systems, For Clinical Use

Clinical Chemistry

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Clinical Chemistry

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Clinical Chemistry