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  • Dispositivo 1229
  • Fabricante 1229
  • Evento 1230
  • Implante 0
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 051 12 13 000
  • Fecha de inicio del evento
    2013-12-05
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4906
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The ingredient that gives hydrophilic properties to this impression material was left out of the formulation. the two different trade names and corresponding lot numbers are listed above.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 070 02 16 000
  • Fecha de inicio del evento
    2016-02-22
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8899
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Recently, during inspection of incoming components from a supplier, 3m discovered a valve with incorrectly labeled “input” and “output” orientation.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 034 08 12 000
  • Fecha de inicio del evento
    2012-08-14
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2191
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Upon a voluntary inspection of the manufacturing process, a potential impairment of the sterility of the above mentioned products were detected.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 051 11 17 000
  • Fecha de inicio del evento
    2017-11-16
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11753
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Programming translation error may lead to temperature readout lower than actual patient temperature.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 061 11 17 000
  • Fecha de inicio del evento
    2017-11-19
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11765
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Programming translation error may lead to temperature readout lower than actual patient temperature.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 137 04 16 000
  • Fecha de inicio del evento
    2016-04-28
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9270
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    3m received two customer reports of leaks associated with 3m ranger high flow disposable set, model 24355, lots hx 7223 and hx 7270.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 103 01 18 000
  • Fecha de inicio del evento
    2018-01-31
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12072
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    3m confirmed that that the affected blankets are more susceptible to unintended occlusion of airflow resulting in partial or limited inflation during use. if blankets are only partially inflated during use in surgery, there is potential for incomplete warming therapy to be given to a patient.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 119 06 13 000
  • Fecha de inicio del evento
    2013-06-25
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3806
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    The subject lots of ur4 crown kits and refills contain ll3 crowns which are incorrectly labeled as ur4 crowns.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 139 09 12 000
  • Fecha de inicio del evento
    2012-09-17
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2394
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Upon a voluntary inspection of the manufacturing process, a potential impairment of the sterility of the above mentioned products were detected.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 027 05 16 000
  • Fecha de inicio del evento
    2016-05-04
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9302
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    An issue has been identified with a small number of 4500md lc/ms/ms systems where under certain conditions, there is the possibility that a user will be presented with incorrect quantitative results.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 164 03 16 000
  • Fecha de inicio del evento
    2016-03-24
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9089
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    An issue has been identified with analyst md software where under certain conditions a user can be presented with incorrect quantitative results.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 115 12 17 000
  • Fecha de inicio del evento
    2017-12-26
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11950
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The purpose of this product correction letter is to inform you fetal hemoglobin (hbf) interference occurs at a level lower than what is stated in the hba1c reagent package insert.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 093 04 18 000
  • Fecha de inicio del evento
    2018-04-22
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12481
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The individual alinity i hbsag calibrator bottles were labelled with an incorrect lot number and barcode. the alinity i hbsag calibrator kit (box) lot is correctly labelled as 83313fn00 whereas the bottles are incorrectly labelled with 83133fn00a to 83133fn00f. if this lot is used with the automated calibration ordering feature the mismatch in the lot numbers will result in an error and an unsuccessful calibration.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 065 09 18 000
  • Fecha de inicio del evento
    2018-09-18
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13173
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    May be susceptible to a krack attack when using wi-fi protected access wireless authentication protocols.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 028 09 18 000
  • Fecha de inicio del evento
    2018-09-12
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13136
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Abbott diagnostics has received the attached urgent field safety notice from inpeco, the manufacturer of accelerator a3600. the transport mechanism component that allows the movement of the robot along the axes generates a magnetic field which at close distance may interfere with the pacemaker/implanted heart defibrillator functionality.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 103 12 18 000
  • Fecha de inicio del evento
    2018-12-24
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13673
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Abbott has identified an issue with the alinity i gear pump assembly (part number a‐30108552‐01) resulting in foaming/bubbling out of the bottle reservoir for concentrated wash buffer and an unexpected amount of dried residue of buffer. the foaming/bubbling is a result of an improper calibration of the pump’s operating speed.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 124 07 18 000
  • Fecha de inicio del evento
    2018-07-24
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12962
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The architect pressure monitoring system helps identify errors during pipetting operations, and error messages are generated to alert the user, should a problem with this system occur. if the system is in the running status when pressure monitoring error code 3586 to 3600 or 5381 is generated, the architect takes appropriate action to protect the integrity of patient test(s). if communication is lost between the architect and the pressure monitoring system, the processing module will be placed into the stopped status until the issue can be addressed. this ensures all tests are monitored by the pressure monitoring system.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 027 03 11 000
  • Fecha de inicio del evento
    2011-03-07
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=194
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    Abbott has identified occurrences where the cell-dyn emerald analyzer generates out-of-range low rbc or low rbc and plt parameters on multiple levels of quality control (qc) when using celldyn emerald cleaner lot #4349. not all customers are experiencing this issue.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 078 05 14 000
  • Fecha de inicio del evento
    2014-05-18
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5850
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The positive control of the architect ebv vca igm control lot 38938li00 has reduced stability. this may result in a higher than expected number of out of range low values. the negative control is not impacted.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 003 08 14 000
  • Fecha de inicio del evento
    2014-08-01
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6225
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    An abbott investigation has identified that the ict serum calibrator lots above may generate lower than expected potassium quality control (qc) and patient results.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 056 10 18 001
  • Fecha de inicio del evento
    2018-11-05
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13444
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR , Swissmedic
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Samples tested using architect free t3 or architect total t3 assays may show depressed results due to reagent carryover when testing on board with the assays specified in table 1 (see attached fsn) .
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 138 05 16 001
  • Fecha de inicio del evento
    2016-05-29
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9417
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Abbott diagnostics has been notified that the manufacturer of the centrifuge recommends an immediate reduction in the operating speed of the centrifuge not to exceed a maximum of 3500 rpms. material changes may have had an impact on the bucket strength, which could lead to the bucket becoming dislodged in the centrifuge.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 134 07 18 000
  • Fecha de inicio del evento
    2018-07-26
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12974
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Abbott has identified the two architect ebv vca igm reagent lots listed above may show reduced rlu (relative light units) signal when used in combination with certain lots of architect ebv vca igm calibrator (ln 3p66‐01).
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 127 11 16 000
  • Fecha de inicio del evento
    2016-11-22
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10280
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    For the architect toxo igm assay an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for the lot numbers above. these sample types share the commonality of low total igm titer.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 083 09 18 000
  • Fecha de inicio del evento
    2018-09-19
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13192
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Abbott has identified an issue with the alinity i bulk solution dispense pumps (part number a‐35001280‐01) resulting in pump failures. the issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution(s) that eventually results in the pump failure.
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