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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Device Recall Simplexa Flu A/B & RSV Direct
  • Modelo / Serial
    Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262.  Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.   3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.
  • Descripción del producto
    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2650, MOL1451, MOL1452, MOL1455
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Simplexa Flu A/B & RSV Direct
Device Recall Simplexa Group A Strep Direct
  • Modelo / Serial
    Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262.  Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.   3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.
  • Descripción del producto
    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2850, MOL1451, MOL1452, MOL1455
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Simplexa Group A Strep Direct
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325
  • Modelo / Serial
    Lot/Serial: 485368220 Expiry: 12-JAN-17
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to China  Taiwan region; No US/military/government distribution.
  • Descripción del producto
    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. || 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 criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. 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 when used as instructed in the Product Information manual.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 739348620 exp. 6/30/16, 739348622 exp. 6/30/16, and 739348623 exp. 6/30/16.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 740340920 exp. 4/14/16, 740350820 exp. 7/22/16, 740356320 exp. 9/15/16, 740361110 exp. 11/2/16, 740371720 exp. 2/16/17, 740386420 exp. 7/13/17, and 740388520 exp. 8/3/17.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 741340920 exp. 4/14/16, 741350820 exp. 7/22/16, 741356320 exp. 9/15/16, 741357020 exp. 9/22/16, and 741366820 exp. 12/29/16.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9/16, 742362540 exp. 11/16/16, 742364020 exp. 12/1/16, 742368210 exp. 1/12/16, 742376540 exp. 4/5/17, 742383610 exp. 6/15/17, and 742389220 exp. 8/10/17.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 743357720 exp. 9/29/16, 743366820 exp. 12/29/16, 743376510 exp. 4/5/17, 743380820 exp. 5/18/17, and 743387820 exp. 7/27/17.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 744357740 exp. 9/29/16, 744383620 exp. 6/15/17, and 744389320 exp. 8/11/17.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 745363420 exp. 11/25/16 and 745375920 exp. 3/30/17.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 746382820 exp. 6/7/17 and 746386520 exp. 7/14/17 .
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 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.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
Device Recall OraQuick HCV Visual Reference Panel
  • Modelo / Serial
    Item Number 1001-0343, Lot # 6648737
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.
  • Descripción del producto
    OraQuick HCV Visual Reference Panel || Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
  • Manufacturer
    OraSure Technologies, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OraQuick HCV Visual Reference Panel
Device Recall Oxoid Nitrocefin ( Reconstitution Fluid Batch)
  • Modelo / Serial
    Lot 1717357 Exp: 31Aug2017
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution in MO.
  • Descripción del producto
    Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Oxoid Nitrocefin ( Reconstitution Fluid Batch)
Device Recall GBS Detect
  • Modelo / Serial
    Lot H16054 and H15056.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
  • Descripción del producto
    Hardy Diagnostics GBS Detect || Cat no. A300. || Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall GBS Detect
Device Recall Roche Molecular Systems
  • Modelo / Serial
    EGFR v2: 07248563190 cfDNA: 07247737190
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Hungary
  • Descripción del producto
    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample || Preparation Hungarian Translation Instructions for Use
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Roche Molecular Systems
Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar
  • Modelo / Serial
    Cat. Number Lot Number 221291 6034889
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
  • Descripción del producto
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar || Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 || Product is sold in cartons of 100 plates each. || Product Usage: || Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar
Device Recall Diamedix IsCMV IgG Test Kit
  • Modelo / Serial
    Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
  • Descripción del producto
    Diamedix Is-CMV IgG Test Kit
  • Manufacturer
    Diamedix Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Diamedix IsCMV IgG Test Kit
Device Recall cobas Liat Analyzer
  • Modelo / Serial
    US-IVD: M1-E-00383 & M1-E-00434
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in NC and WA.
  • Descripción del producto
    cobas¿ Liat¿ Analyzer
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall cobas Liat Analyzer
Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute
  • Modelo / Serial
    Lot 111WH3
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
  • Descripción del producto
    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 || The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
  • Manufacturer
    Immuno-Mycologics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute
Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT ...
  • Modelo / Serial
    Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to CA only.
  • Descripción del producto
    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T || The product is used as an aid in the identification of Staphylococcus aureus from Culture
  • Manufacturer
    Integrated Science Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT Staph ID
Device Recall cobas Liat Influenza A/B Quality Control Kit
  • Modelo / Serial
    Lot Numbers: 51222E, 60121H, 60201D, and 60229F
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
  • Descripción del producto
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall cobas Liat Influenza A/B Quality Control Kit
Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack
  • Modelo / Serial
    Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. || For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack
Device Recall Dako HER2 CISH pharmDx Kit
  • Modelo / Serial
    20031683
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey.
  • Descripción del producto
    Dako HER2 CISH pharmDx Kit, product code: SK 109 || Product Usage: || For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
  • Manufacturer
    Dako North America Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Dako HER2 CISH pharmDx Kit
Device Recall Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma)
  • Modelo / Serial
    all lots are affected
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US
  • Descripción del producto
    Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
  • Manufacturer
    Alere San Diego, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma)
Device Recall Cardinal Health Mono Rapid Test
  • Modelo / Serial
    all lots are affected
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US
  • Descripción del producto
    Cardinal Health Mono Rapid Test, Catalog No. B1077-28, || a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
  • Manufacturer
    Alere San Diego, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cardinal Health Mono Rapid Test
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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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La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

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