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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
BACTEC" FX InstrumentTop
  • Modelo / Serial
    Catalog # 441385-Serial numbers: FT-0001 to FT-0906 and FT-0922
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.
  • Descripción del producto
    BACTEC" FX Instrument-Top, catalog #441385. || The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de BACTEC" FX InstrumentTop
BD ProbeTec" CT/GC/AC Reagent Pack
  • Modelo / Serial
    Lot 0158908 exp May 31, 2011 and Lot 0158969 exp May 31, 2011
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, KY, LA, ME, MN, MO, MS, MT, NE, OH, PA, RI, TX, and WA and the countries of Australia, Canada, Europe, and Japan.
  • Descripción del producto
    BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** || The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper" instrument.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de BD ProbeTec" CT/GC/AC Reagent Pack
BBL DrySlide PYR kit
  • Modelo / Serial
    PYR kit - lot 2276481 with expiration date 09/30/13
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
  • Descripción del producto
    BBL DrySlide PYR Kit, catalog number 231747 || Product Usage: || Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de BBL DrySlide PYR kit
BBL DrySlide Oxidase kit
  • Modelo / Serial
    Oxidase kit - lot 2222008 with expiration date 08/31/13
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
  • Descripción del producto
    BBL DrySlide Oxidase Kit, catalog number 231746 || Product Usage: || Presumptive diagnostic aid for gram-negative bacteria.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de BBL DrySlide Oxidase kit
remel RapID Yeast Plus System
  • Modelo / Serial
    Lot 302532, Exp 6 Feb 2014
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, WI and the countries of Canada, UK, and Japan.
  • Descripción del producto
    remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. || Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de remel RapID Yeast Plus System
WASP (Walk Away Specimen Process) Instrument software
  • Modelo / Serial
    Serial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Oregon and California., and the countries of France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan
  • Descripción del producto
    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument || Catalog number: W086 || WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
  • Manufacturer
    Copan Italia
  • 1 Event
    • Retiro De Equipo (Recall) de WASP (Walk Away Specimen Process) Instrument software
illumipro10 Incubator/Reader
  • Modelo / Serial
    Serial Numbers: IP2669, IP2670, IP2671, IP2672, IP2673, IP2674, IP2675, IP2676, IP2677, IP2678, IP2680, IP2682, IP2683, IP2684, IP2685, IP2686, IP2687, IP2688, IP2689, IP2690, IP2691, IP2692, IP2693, IP2694, IP2695, IP2696, IP2697, IP2698, IP2699, IP2700, IP2701, IP2702, IP2703, IP2704, IP2705, IP2706.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV. Internationally to Australia.
  • Descripción del producto
    illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. || The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
  • Manufacturer
    Meridian Bioscience Inc
  • 1 Event
    • Retiro De Equipo (Recall) de illumipro10 Incubator/Reader
Neogen
  • Modelo / Serial
    7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
  • Descripción del producto
    Tryptic Soy Agar, Acumedia PN 7100 || 500g, 2Kg, 10Kg, and 50Kg sizes
  • Manufacturer
    Acumedia Manufacturers, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Neogen
VITEK 2 GN ID
  • Modelo / Serial
    241396010 17/Oct/17 241398120 07/Nov/17 241398420 10/Nov/17 241398620 12/Nov/17 241398720 13/Nov/17 241398820 14/Nov/17 241399520 21/Nov/17 2410000203 26/Nov/17 2410002203 28/Nov/17 2410006203 02/Dec/17 2410007203 03/Dec/17 2410008203 04/Dec/17 2410009103 05/Dec/17 2410031103 27/Dec/17 2410033103 29/Dec/17 2410034103 30/Dec/17 2410037103 02/Jan/18 2410038103 03/Jan/18 2410041103 06/Jan/18 2410042103 07/Jan/18 2410043103 08/Jan/18 2410044203 09/Jan/18 2410047203 12/Jan/18 2410052103 17/Jan/18 2410057103 22/Jan/18 2410058103 23/Jan/18 2410063103 28/Jan/18 2410064103 29/Jan/18 2410065103 30/Jan/18 2410071103 05/Feb/18 2410072103 06/Feb/18 2410078103 12/Feb/18 2410083103 17/Feb/18 2410085203 19/Feb/18 2410086103 20/Feb/18 2410088103 22/Feb/18 2410091203 25/Feb/18 2410092103 26/Feb/18 2410093103 27/Feb/18 2410097103 03/Mar/18 2410098103 04/Mar/18 2410099103 05/Mar/18 2410100103 06/Mar/18 2410105203 11/Mar/18 2410106103 12/Mar/18 2410107203 13/Mar/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK 2 GN ID
Vitek 2 GP ID
  • Modelo / Serial
    2420157103 02/May/18 2420164103 09/May/18 2420169103 14/May/18 2420174203 19/May/18 2420185103 30/May/18 2420198203 12/Jun/18 2420200103 14/Jun/18 2420204103 18/Jun/18 2420205103 19/Jun/18 2420220203 04/Jul/18 2420229203 13/Jul/18 2420239203 23/Jul/18 2420253203 06/Aug/18 2420267103 20/Aug/18 2420290103 12/Sep/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vitek 2 GP ID
Vitek 2 YST ID
  • Modelo / Serial
    2430199103 13/Jun/18 2430199123 13/Jun/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vitek 2 YST ID
Vitek 2 NH ID
  • Modelo / Serial
    2450129203 04/Apr/18 2450162203 07/May/18 2450204203 18/Jun/18 2450221203 05/Jul/18 2450288203 10/Sep/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vitek 2 NH ID
Vitek 2 ANC ID
  • Modelo / Serial
    2440168103 13/May/18 2440202103 16/Jun/18 2440293203 15/Sep/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vitek 2 ANC ID
Acumedia Urea Base Agar
  • Modelo / Serial
    PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
  • Descripción del producto
    Urea Base Agar, Acumedia PN 7226 || Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
  • Manufacturer
    Acumedia Manufacturers, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Acumedia Urea Base Agar
Acumedia Sabouraud Dextrose Agar w /Lecithin and Tween 20
  • Modelo / Serial
    PN 91081C, Lot 108367A PN 91081C, Lot 107632A
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US in the state of IL
  • Descripción del producto
    Sabouraud Dextrose Agar w /Lecithin and Tween 20 || Acumedia PN 91081 || Product Usage: || Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
  • Manufacturer
    Acumedia Manufacturers, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Acumedia Sabouraud Dextrose Agar w /Lecithin and Tween 20
VIDAS
  • Modelo / Serial
    Lot Numbers: 040212-0, 040218-0 Expiration date: 2/2004
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA
  • Descripción del producto
    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use || Product Number: 30101
  • Manufacturer
    bioMerieux
  • 1 Event
    • Retiro De Equipo (Recall) de VIDAS
BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
  • Modelo / Serial
    Lot numbers: 3129508 exp 1/30/04 3129509 exp 2/3/04 3129506 exp 2/3/04 3129512 exp 2/3/04
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was sold to 11 distributors and one end user in the US. Product was additionally distributed to firm''s subsidiaries in Canada and Europe.
  • Descripción del producto
    BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
Remel Chocolate Agar
  • Modelo / Serial
    Lot #435902, Exp. 2004-11-04
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK.
  • Descripción del producto
    Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.
  • Manufacturer
    Remel, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Remel Chocolate Agar
The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is de...
  • Modelo / Serial
    ETI-Mumps Assay software version 1.0
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.
  • Descripción del producto
    The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).
  • Manufacturer
    Diasorin Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).
VersaTREK Myco AS.
  • Modelo / Serial
    lot code 144365, expiration date 2005/11.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The product was distributed to consignees located in AL, IA, IL, MD, NJ, OH, PA, Washington D.C. and to two foreign distributors: I.L. Diagnostics, Lago Victoria No. 80, Col. Granada, Mexico D.F., 11520; and Trivitron Diagnostics, #15 4th Street, Abhiramapuram, Chennai, India 600-018.
  • Descripción del producto
    VersaTREK Myco AS.
  • Manufacturer
    Trek Diagnostic Systems
  • 1 Event
    • Retiro De Equipo (Recall) de VersaTREK Myco AS.
BacT/ALERT
  • Modelo / Serial
    Lot number 1013177 (Product No. 259790)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.
  • Descripción del producto
    bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de BacT/ALERT
BD BBL Staphyloslide Latex Test Kit
  • Modelo / Serial
    Lot Number / Exp. Date 16629910 April 30, 2007-Cat # 240952 16562410 April 30, 2007-Cat # 240952 16629920 April 30, 2007-Cat # 240953 16562420 April 30, 2007-Cat # 240953
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-product was sold to distributors and end users
  • Descripción del producto
    BD¿ BBL¿ Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de BD BBL Staphyloslide Latex Test Kit
BacT/ALERT
  • Modelo / Serial
    All Models
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Descripción del producto
    BacT/ALERT 3D 60 Systems Software, Blood Culturing System
  • Manufacturer
    bioMerieux, Inc.
  • 4 Event
    • Retiro De Equipo (Recall) de BacT/ALERT
    • Retiro De Equipo (Recall) de BacT/ALERT
    • Retiro De Equipo (Recall) de BacT/ALERT
    • Retiro De Equipo (Recall) de BacT/ALERT
Anaerotest
  • Modelo / Serial
    Item number 1.19034.0002 Lot # OC553145
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
  • Descripción del producto
    Anaerotest for microbiology || Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes || Merck KgaA || 64271 Darmstadt, Germany || 1.19034.0002 17.08.06 1 unit || UPC 4 022536 667928
  • Manufacturer
    EMD Chemicals Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Anaerotest
Anaerotest
  • Modelo / Serial
    Item # 1.15112.0001 Lot # OC553145
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
  • Descripción del producto
    Anaerotest;Microbiology , || 50 test strips || 1.15112 || Store dry and tightly closed. || Store at + 15 C to +25C || Merck IVD || 64271 Darmstadt, Germany
  • Manufacturer
    EMD Chemicals Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Anaerotest
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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