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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Device Recall Acute Care MYO TestPak
  • Modelo / Serial
    Lot Numbers: 515146002, 515201002, 515285002
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma || Catalog Number: CMYO || SMN:10445079
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care MYO TestPak
Device Recall Acute Care CCRP CalPak
  • Modelo / Serial
    Lot Number: 425229002
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer || Catalog Number: CCCRP || SMN:10445066
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care CCRP CalPak
Device Recall Acute Care CCRP CalPak
  • Modelo / Serial
    Lot Numbers: 625229002
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer || Catalog Number: CCCRP-C || SMN:10445067
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care CCRP CalPak
Device Recall Acute Care MYO DilPak
  • Modelo / Serial
    Lot Numbers: 815131002, 815222002
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care MYO DilPak || Catalog Number: CMYO-D || SMN:10445081 || in vitro diagnostic
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care MYO DilPak
Device Recall Etest
  • Modelo / Serial
    Ref. 412434, Lot numbers: 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490 and  1001936360.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
  • Descripción del producto
    Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW || Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
  • Manufacturer
    Biomerieux
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Etest
Device Recall Etest
  • Modelo / Serial
    Ref. 412433, Lot numbers: 1004394540, 1003903640, 1003558430, 1003069250, 1002372580 and 1001938220
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
  • Descripción del producto
    Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. || Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
  • Manufacturer
    Biomerieux
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Etest
Device Recall Etest
  • Modelo / Serial
    Ref. 521418, Lot numbers: 1004398470, 1004276460, 1004180840, 1003980200, 1003699550, 1003416920, 1003105180, 1002995820, 1002482640, 1002375410, 1002276210 and 1002092270.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
  • Descripción del producto
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. || Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
  • Manufacturer
    Biomerieux
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Etest
Device Recall Etest
  • Modelo / Serial
    Ref. 521458, Lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620 and 1002120370.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
  • Descripción del producto
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. || Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
  • Manufacturer
    Biomerieux
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Etest
Device Recall Granada Biphasic Broth
  • Modelo / Serial
    REF 42722 - Lot Numbers 896, 897 & 899
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
  • Descripción del producto
    Granada Biphasic Broth || The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Granada Biphasic Broth
Device Recall MicroScan Pos Combo Panel Type 21
  • Modelo / Serial
    2016-05-05 Part No. B1017-201
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
  • Descripción del producto
    MicroScan Pos Combo Panel Type 21, Part No. B1017-201 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MicroScan Pos Combo Panel Type 21
Device Recall MicroScan Pos Combo Panel Type 33
  • Modelo / Serial
    2016-04-29 2016-05-04 Part No. B1017-211
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
  • Descripción del producto
    MicroScan Pos Combo Panel Type 33, Part No. B1017-211 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MicroScan Pos Combo Panel Type 33
Device Recall MicroScan Pos Combo Panel Type 34
  • Modelo / Serial
    2016-04-29 2016-05-06 Part No. B1017-214
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
  • Descripción del producto
    MicroScan Pos Combo Panel Type 34, Part No. B1017-214 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MicroScan Pos Combo Panel Type 34
Device Recall MicroScan Pos Breakpoint Combo Panel Type 20
  • Modelo / Serial
    2016-04-30 Part No. B1017-202
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
  • Descripción del producto
    MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MicroScan Pos Breakpoint Combo Panel Type 20
Device Recall MicroScan Pos Breakpoint Combo Panel Type 23
  • Modelo / Serial
    2016-05-06 Part No. B1017-206
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
  • Descripción del producto
    MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 || MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MicroScan Pos Breakpoint Combo Panel Type 23
Device Recall FB Broth
  • Modelo / Serial
    Cat. no. K31 Lot no.15231
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US. Distribution to the states of : CA, WI, MD and UT. .
  • Descripción del producto
    FB Broth, 10ml || (Fastidious Bacteria Broth) || Cat. no: K31 Lot: 15231 || A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall FB Broth
Device Recall EliA
  • Modelo / Serial
    Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
  • Descripción del producto
    EliA SmDP Well, Article Number 14-5624-01 || Product Usage: || EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
  • Manufacturer
    Phadia Ab
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall EliA
Device Recall Advia centaur PSA assay
  • Modelo / Serial
    SMN 10310292-100 test kits Lot# UDI # 54637263 0063041420300354637263160223 55304263 0063041420300355304263160223 56249264 0063041420300356249264160327 76727264 0063041420300376727264160327 00825265 0063041420300300825265160424 92416265 0063041420300392416265160424 99151265 0063041420300399151265160424 12970266 0063041420300312970266160721 14158266 0063041420300314158266160721 23016266 0063041420300323016266160721 28881266 0063041420300328881266160721 40776268 0063041420300340776268160922  SMN 10310293-500 test kits Lot# UDI # 54448263 0063041420299054448263160223 55171263 0063041420299055171263160223 56171264 0063041420299056171264160327 77560264 0063041420299077560264160327 92415265 0063041420299092415265160424 96996265 0063041420299096996265160424 12971266 0063041420299012971266160721 13429266 0063041420299013429266160721 19651266 0063041420299019651266160721 27278266 0063041420299027278266160721 35089266 0063041420299035089266160721 39805268 0063041420299039805268160922 50851268 0063041420299050851268160922
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR, AU, BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.
  • Descripción del producto
    ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) || Product Usage: || This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Advia centaur PSA assay
Device Recall BacT/ALERT SN
  • Modelo / Serial
    Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
  • Descripción del producto
    BacT/ALERT¿ SN, bioM¿rieux, Inc. || Product Usage: || BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BacT/ALERT SN
Device Recall BacT/ALERT FA
  • Modelo / Serial
    Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
  • Descripción del producto
    BacT/ALERT¿ FA, bioM¿rieux, Inc., || Product Usage: || BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BacT/ALERT FA
Device Recall API ZYM B (Ref 70493)
  • Modelo / Serial
    Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY
  • Descripción del producto
    API ZYM Bx2 (Ref 70493) || Product Usage: || ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall API ZYM B (Ref 70493)
Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridge
  • Modelo / Serial
    Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution and US in the state of CA.
  • Descripción del producto
    Dimension Vista System || B2 Microglobulin Flex reagent cartridge and urine stabilizer || Catalog #K7024 SMN: 10445889 Lot #15246MA || Product Usage: || The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridge
Device Recall Northeast Laboratory Services (NEL)
  • Modelo / Serial
    Al lot codes
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube || Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
  • Manufacturer
    Northeast Laboratory Services, Inc.
  • 2 Events
    • Retiro De Equipo (Recall) de Device Recall Northeast Laboratory Services (NEL)
    • Retiro De Equipo (Recall) de Device Recall Northeast Laboratory Services (NEL)
Device Recall QuantiFERON TBGold
  • Modelo / Serial
    CODE(S):   a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016  b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016  c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016  d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016  e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
  • Descripción del producto
    QFT TB Antigen Tube. || QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
  • Manufacturer
    Qiagen Sciences LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall QuantiFERON TBGold
Device Recall VITEK 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
    Lots 736336020 exp. 2/25/16, 736340920 exp. 4/14/16, and 736388620 exp. 8/4/17.
  • 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-P636 REF 417951), 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 Simplexa" HSV 1 & 2 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 HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2150, MOL1451, MOL1452, MOL1455
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Simplexa" HSV 1 & 2 Direct
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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.