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  • Dispositivo 25
  • Fabricante 5
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de AQUIOS CL Flow Cytometry System
  • Tipo de evento
    Recall
  • ID del evento
    22097
  • Fecha de inicio del evento
    2017-12-05
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Causa
    The manufacturer is advising that when aquios cl systems are connected to a laboratory information system (lis), the system may duplicate sample requests leading to sample mis-identification., this is an updated notification in follow-up to the previous communication received (dated 16 october 2017) concerning duplicate sample requests leading to sample mis-identification when using the aquios cl systems connected to a laboratory information system (lis). this important information needs immediate attention. the information replaces the instructions in the original notification dated 16 october 2017.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de LO - Orthopeaedic Implant inserter / Extractor -12696
  • Tipo de evento
    Recall
  • ID del evento
    22117
  • Fecha de inicio del evento
    2017-10-18
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Lima Orthopaedics New Zealand Ltd, 20 Crummer Road, Grey Lynn, AUCKLAND 1021
  • Causa
    The manufacturer has detected a defective welding by the supplier on all the broken instruments received. specifically, the absence of base material pre-fusion and under-dimensioned welding radius was identified.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de A&E Aorta Punch
  • Tipo de evento
    Recall
  • ID del evento
    22144
  • Fecha de inicio del evento
    2017-10-24
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    There is potential packaging damage to have occurred during transportation, resulting in a loss of sterility. recent testing has identified certain shipping configurations which may cause damage to the sterile barrier pouch if the surgical punches experience excessive movement from multiple drops during transport.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de ACUVUE contact lens, extended-wear
  • Tipo de evento
    Recall
  • ID del evento
    22150
  • Fecha de inicio del evento
    2017-10-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
  • Causa
    Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de ACUVUE contact lens, daily-wear
  • Tipo de evento
    Recall
  • ID del evento
    22150
  • Fecha de inicio del evento
    2017-10-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
  • Causa
    Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de ACUVUE contact lens, daily-disposable
  • Tipo de evento
    Recall
  • ID del evento
    22150
  • Fecha de inicio del evento
    2017-10-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
  • Causa
    Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
  • Acción
    Product to be returned to supplier
Alerta De Seguridad para BLOOD BAGS CPD SAG-M.
  • Tipo de evento
    Safety alert
  • ID del evento
    ALERTA DIGEMID Nº 29 - 2015
  • Fecha
    2015-05-27
  • País del evento
    Peru
  • Fuente del evento
    Digemid
  • URL de la fuente del evento
    http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Alertas/2015/ALERTA_29-15.pdf
  • Notas / Alertas
    Peruvian data is current through August 2018. All of the data comes from Digemid, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Peru.
  • Notas adicionales en la data
  • Causa
    Health record expired.
Retiro De Equipo (Recall) de ACUVUE Bandage Lens
  • Tipo de evento
    Recall
  • ID del evento
    22150
  • Fecha de inicio del evento
    2017-10-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
  • Causa
    Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Heater Cooler Unit
  • Tipo de evento
    Recall
  • ID del evento
    22177
  • Fecha de inicio del evento
    2017-11-01
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • Causa
    Even though hcu 20 and hcu 30 do not emit contaminated aerosols, the manufacturer developed and validated new safe and user-friendly water quality management procedures to be implemented on all hcu 20 and hcu 30 systems in the field.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Cook Inc - Guide Wire
  • Tipo de evento
    Recall
  • ID del evento
    22185
  • Fecha de inicio del evento
    2017-11-03
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    The manufacturer has identified that the label of heparin coated devices does not explicitly state that they are heparin coated. the products are labeled with the correct catalog identifier, which includes the suffix bh that indicates the product is heparin coated. however, users who are not familiar with the bh nomenclature may not be aware that the product contains heparin.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Cleveland CT
  • Tipo de evento
    Recall
  • ID del evento
    22197
  • Fecha de inicio del evento
    2017-11-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    The manufacturer has become aware of a potential problem with our philips brilliance 64/ ingenuity family version 4.1.6 as detailed below:, issue 1: cardiac signal not found in workflow issue, issue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to start, issue 3: pulmo gates on cardiac workflow issue, issue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well., issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results, issue 6: application may fail when modifying the results plan box during 3d calcium score, issue 7: tube too hot, issue 8: memory overflow issue, issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message, issue 10: issue with the generatormonitor state machine in rhost code issue.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Siemens Somatom CT Systems
  • Tipo de evento
    Recall
  • ID del evento
    22215
  • Fecha de inicio del evento
    2017-11-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer is aware of a potential risk of unnecessary radiation exposure due to a software issue found in the care dose4d algorithm implemented in the siemens healthineers ct scanners.
  • Acción
    Manufacturer to issue advice regarding use
Alerta De Seguridad para unkown device
  • Tipo de evento
    Safety alert
  • ID del evento
    ALERTA DIGEMID Nº 31 - 2016
  • Fecha
    2016-06-24
  • País del evento
    Peru
  • Fuente del evento
    Digemid
  • URL de la fuente del evento
    http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Alertas/2016/ALERTA_31-16.pdf
  • Notas / Alertas
    Peruvian data is current through August 2018. All of the data comes from Digemid, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Peru.
  • Notas adicionales en la data
  • Causa
    Without sanitary registry.
Retiro De Equipo (Recall) de Prosthesis, Internal, Stent, Vascular
  • Tipo de evento
    Recall
  • ID del evento
    22217
  • Fecha de inicio del evento
    2017-11-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Causa
    Partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de ELUVIA™ Drug-Eluting Vascular Stent System
  • Tipo de evento
    Recall
  • ID del evento
    22217
  • Fecha de inicio del evento
    2017-11-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Causa
    Partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de MAQUET HLX 2004-5 DF
  • Tipo de evento
    Recall
  • ID del evento
    22227
  • Fecha de inicio del evento
    2017-11-08
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • Causa
    From the manufacturer investigation it was concluded that the issue relates to a crack in the metal of the spring arms that has the potential to develop into a break. these paticular devices are over ten years old and even so the vast majority have not failed.
  • Acción
    Product to be modified
Retiro De Equipo (Recall) de DxH500 open-Vial Hematology System
  • Tipo de evento
    Recall
  • ID del evento
    22229
  • Fecha de inicio del evento
    2017-11-08
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Causa
    An internal investigation has identified that if the bleach cycle is interrupted or aborted, the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted, the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Bard Australia Pty Ltd - Heating unit, pad, water
  • Tipo de evento
    Recall
  • ID del evento
    22236
  • Fecha de inicio del evento
    2017-11-09
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Causa
    The manufacturer has determined that this issue affects specific lots of arcticgel ™ pad kits. the affected units have the potential for there to be insufficient adhesion of the hydrogel to the pad. this can be easily identified if the hydrogel peels away with the release liner.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de VITEK 2 Gram Positive- ID Card
  • Tipo de evento
    Recall
  • ID del evento
    22243
  • Fecha de inicio del evento
    2017-11-10
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Causa
    An internal investigation has confirmed, occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc® 700327™ in association with three(3) vitek® 2 gp id, causing failure of the quality control (qc) testing for the vitek® 2 gp id card. in accordance with the vitek® 2 gp id instructions for use, the expected o129r reaction for atcc® 700327™ strain is positive. as a precaution, the manufacturer is also including in the scope of this notice all gp id card lots manufactured with the same raw materials.
  • Acción
    Product to be destroyed
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