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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Device Recall Oxoid Legionella BCYE Growth Supplement SR0110A
  • Modelo / Serial
    Lot No. 1545171
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : MI, ND, SC, TN, and TX.
  • Descripción del producto
    Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Oxoid Legionella BCYE Growth Supplement SR0110A
Device Recall Vitek 2 ASTP635 REF 416 911
  • Modelo / Serial
    lot 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • Descripción del producto
    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. || 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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitek 2 ASTP635 REF 416 911
Device Recall Vitek 2 ASTP640 REF 418 579
  • Modelo / Serial
    lot 740340920, expiration 14APR16; lot 740350820, expiration 22JUL16;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • Descripción del producto
    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. || 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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitek 2 ASTP640 REF 418 579
Device Recall Vitek 2 ASTP641 REF 418 590
  • Modelo / Serial
    lot 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • Descripción del producto
    Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. || 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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitek 2 ASTP641 REF 418 590
Device Recall HardyCHROM SS Agar
  • Modelo / Serial
    Lot no. 15037, Expires: 00-00-2000
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
  • Descripción del producto
    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar || (HardyCHROM Salmonella Shigella) || Cat no: G327 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2 to 8 degrees C. on receipt in dark || A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HardyCHROM SS Agar
Device Recall STRATIFY JCV DxSelect
  • Modelo / Serial
    Lot No. 27333
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Internationally: Denmark only.
  • Descripción del producto
    STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall STRATIFY JCV DxSelect
Device Recall Vitek 2 ASTYS06 REF 412 610
  • Modelo / Serial
    lot 286303720, expiration 08-APR-15
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
  • Descripción del producto
    Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitek 2 ASTYS06 REF 412 610
Device Recall Vitek 2 ASTYS07 REF 414 967
  • Modelo / Serial
    lot 287303120, 02-APR-15; lot 287303122, 02-APR-15; lot 287306710, 08-MAY-15; lot 287308210, 23-MAY-15; lot 287311710, 27-JUN-15; lot 287314910, 29-JUL-15; lot 287314912, 29-JUL-15; lot 287315710, 06-AUG-15; lot 287317310, 22-AUG-15; lot 287317710, 26-AUG-15; lot 287318920, 07-SEP-15; lot 287319110, 09-SEP-15; lot 287319820, 16-SEP-15; lot 287321940, 07-OCT-15; lot 287322540, 13-OCT-15; lot 287323520, 23-OCT-15; lot 287324220, 30-OCT-15; lot 287324240, 30-OCT-15; lot 287326220, 19-NOV-15; lot 287327620, 03-DEC-15; lot 287329620, 23-DEC-15; lot 287330520, 01-JAN-16; lot 287331920, 15-JAN-16; lot 287332520, 21-JAN-16; lot 287332522, 21-JAN-16; lot 287334810, 13-FEB-16; lot 287335420, 19-FEB-16; lot 287336220, 27-FEB-16; lot 287337620, 12-MAR-16; lot 287338020, 16-MAR-16; lot 287340140, 06-APR-16; lot 287341820, 23-APR-16; lot 287341822, 23-APR-16; lot 287344620, 21-MAY-16; lot 287344622, 21-MAY-16; lot 287346710, 11-JUN-16; lot 287346720, 11-JUN-16; lot 287350120, 15-JUL-16; and lot 287350122, 15-JUL-16.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
  • Descripción del producto
    Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitek 2 ASTYS07 REF 414 967
Device Recall Vitek 2 ASTYS01 REF 22 108
  • Modelo / Serial
    lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
  • Descripción del producto
    Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitek 2 ASTYS01 REF 22 108
Device Recall MicroScan Neg Breakpoint Combo 34
  • Modelo / Serial
    Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.
  • Descripción del producto
    MicroScan -Neg Breakpoint Combo Panel Type 34; || Catalog number B1017-404; Panel || MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to || No.1 the species level of colonies, grown 34 on solid media, of rapidly growing || aerobic and facultative anaerobic gram-positive bacteria
  • Manufacturer
    Beckman Coulter, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MicroScan Neg Breakpoint Combo 34
Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202
  • Modelo / Serial
    Lot Number: 646595 and 646596 Expiration date: 19May2015
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). || Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202
Device Recall VersaTREK Automated Microbial Detection System
  • Modelo / Serial
    Serial numbers: 0169039201140624, 0169040501140626, 0169050101141007, 0169068601141216, 0169078101150213, 2163X1013, 2164X1013, 2165X1013, 2166X1013, 2167X1013, 2168X1013, 2169X1013, 2170X1013, 2171X1013, 2172X1013, 2173X1013, 2174X1013, 2175X1013, 2176X1013, 2177X1013, 2178X1013, 2179X1013, 2180X1013, 2181X1013, 2182X1013, 2183X1013, 2184X1013, 2185X1013, 2186X1013, 2187X1013, 2188X1013, 2189X1013, 2190X1013, 2191X1013, 2192X1113, 2193X1113, 2194X1113, 2195X1113, 2196X1113, 2199X1113, 2201X1113, 2202X1113, 2203X1113, 2204X1113, 2205X1113, 2206X1113, 2207X1113, 2208X1113, 2209X1113, 2210X1113, 2211X1113, 2212X1113, 2213X1113, 2214X1113, 2216X1113, 2217X1113, 2218X1213, 2219X1213, 2220X1213, 2221X1213, 2222X1213, 2223X1213, 2224X1213, 2225X1213, 2226X1213, 2227X1213, 2228X1213, 2229X1213, 2230X1213, 2231X1213, 2232X1213, 2233X1213, 2234X1213, 2235X1213, 2237X1213, 2238X1213, 2239X1213, 2240X1213, 2241X1213, 2242X1213, 2243X1213, 2245X1213, 2249X0114, 2250X0114, 2251X0114, 2252X0114, 2253X0114, 2254X0114, 2255X0114, 2256X0114, 2257X0114, 2261X0114, 2262X0114, 2263X0114, 2264X0114, 2268X0114, 2269X0114, 2276X0214, 2277X0214, 2278X0214, 2279X0214, 2280X0214, 2281X0214, 2282X0214, 2286X0214, 2287X0214, 2288X0214, 2289X0214, 2290X0214, 2306X0714, 2307X0714, 2309X0714, 2311X0714, 2312X0714, 2314X0714, 2315X0714, 2316X0714, 2317X0714, 2318X0714, 2320X0714, 2321X0814, 2322X0814, 2323X0814, 2330X0814, 2332X0814, 2333X0814, 2334X0814, 2336X0814, 2337X0814, 2338X0814, 2339X0814, 2340X0814, 2342X0814, 2345X0914, 2346X0914, 2347X0914, 2348X0914, 2349X0914, 2352X0914, 2353X0914, 2359X0914, 2365X0914, and 2366X0914;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
  • Descripción del producto
    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VersaTREK Automated Microbial Detection System
Device Recall IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress
  • Modelo / Serial
    Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.
  • Descripción del producto
    IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. || For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress
Device Recall VersaTREK Automated Microbial Detection System
  • Modelo / Serial
    Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
  • Descripción del producto
    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VersaTREK Automated Microbial Detection System
Device Recall Etest CEFOTAXIME CT 256
  • Modelo / Serial
    1002774320, 1002377890, 1002590470, 1002775330, 1002379610
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
  • Descripción del producto
    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Etest CEFOTAXIME CT 256
Device Recall HardyCHROM VRE Agar
  • Modelo / Serial
    Cat No.: G333 Lot No.: H15055
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to one U.S. customer in SC.
  • Descripción del producto
    HardyCHROM VRE Agar-RSR || Cat no: GA333 Lot no: H15055 || Expires: 2015-07-04 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage 2 to 8 degrees C on receipt || Chromogenic medium for stool pathogen screening.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HardyCHROM VRE Agar
Device Recall Alere i flu, Alere i, Alere Influenza A & B
  • Modelo / Serial
    Lot Number 0073853 (US distribution only)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.
  • Descripción del producto
    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 || The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
  • Manufacturer
    Alere Scarborough, Inc. dba Binax, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Alere i flu, Alere i, Alere Influenza A & B
Device Recall MacConkey Agar with Ciprofloxacin
  • Modelo / Serial
    Lot number: 15096 and 15107
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide Distribution and the country of: Canada
  • Descripción del producto
    Hardy Diagnostics || MacConkey Agar with CiPRP, 1ug/ml || Container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MacConkey Agar with Ciprofloxacin
Device Recall Brain Heart Infusion Broth with Ciprofloxacin
  • Modelo / Serial
    Lot number: 15055, 15083, and 15091
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide Distribution and the country of: Canada
  • Descripción del producto
    Hardy Diagnostics || BHI with CIPRO, 1ug/ml || container type: 16x100mm tube || packaged: 20 tubes/box || Product Usage: || Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Brain Heart Infusion Broth with Ciprofloxacin
Device Recall PathoDx Strep Grouping Kit
  • Modelo / Serial
    lot 1470133, exp. date 31 Mar 2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, including Puerto Rico and the country of Canada.
  • Descripción del producto
    PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. || Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PathoDx Strep Grouping Kit
Device Recall PathoDx Strep B Grouping Latex
  • Modelo / Serial
    lot 1463129, exp. date 31 May 2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, including Puerto Rico and the country of Canada.
  • Descripción del producto
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. || Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PathoDx Strep B Grouping Latex
Device Recall MDR Acinetobacter
  • Modelo / Serial
    Lot number: 15092, 15101, 15113 Cat no. G259
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide Distribution and the country of: Canada
  • Descripción del producto
    Hardy Diagnostics || MDR Acinetobacter || container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MDR Acinetobacter
Device Recall BEA (Bile Esculin Agar) with Azide and Vancomycin
  • Modelo / Serial
    Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide Distribution and the country of: Canada
  • Descripción del producto
    Hardy Diagnostics || BEA Agar with Vancomycin || container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BEA (Bile Esculin Agar) with Azide and Vancomycin
Device Recall BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B
  • Modelo / Serial
    Lot number: 15105 Cat no. G107
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide Distribution and the country of: Canada
  • Descripción del producto
    Hardy Diagnostics || BEA Agar with VGA || container type: 15x100mm monoplate || packaged: 10 places/sleeve || Product Usage: || BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B
Device Recall BEA (Bile Esculin Azide) Broth with Vancomycin
  • Modelo / Serial
    Lot number: 15070 Cat no. R98  Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide Distribution and the country of: Canada
  • Descripción del producto
    Hardy Diagnostics || BEA Broth with Vancomycin || container type: 13x100mm tube || packaged: 20 tubes/box || fill: 2ml || Product Usage: || BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BEA (Bile Esculin Azide) Broth with Vancomycin
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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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