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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
The manufacturer is reinforcing that the use of unapproved drug formulations can increase the risk of pump motor stall due to corrosion in the synchromed infusion systems. use of unapproved drugs or fluids can result in increased risks to the patient and permanent damage to the pump.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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
This action refers to a potential issue regarding sterility of the needle passers in this system in extreme shipping and handling situations.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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 has provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
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.
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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
Causa
The manufacturer has issued a software upgrade for the cme pumps to addresses the issue of under infusion by instructing the pump mechanism to move to the nearest optimum resting position for the pumping fingers once the bolus has been given.
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
Through investigation of customer complaints manufacturer has confirmed occurrences of the system either:, 1. failing to detect that the wash 1 bottle and reservoir is empty, or, 2. incorrectly indicating that the wash 1 bottle and reservoir is empty when it is actually full.
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
Through investigation of customer complaints manufacturer has confirmed occurrences of the system either:, 1. failing to detect that the wash 1 bottle and reservoir is empty, or, 2. incorrectly indicating that the wash 1 bottle and reservoir is empty when it is actually full.
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.
The manufacturer has identified that in the real time cmv application specification file m2000 cmv plasma, the upper limits for several processing timers were set such that when samples are run in batch sizes between 49 and 88, the timers on the m2000 may exceed the limits. consequently sample #49 through the last sample in the run would be tagged with warning code.
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.
The manufacturer has identified that in the real time cmv application specification file m2000 cmv plasma, the upper limits for several processing timers were set such that when samples are run in batch sizes between 49 and 88, the timers on the m2000 may exceed the limits. consequently sample #49 through the last sample in the run would be tagged with warning code.
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: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
Causa
Remote possibility of the cable neutral and ground wires to be reveresed on the interface box appliance connector.
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 access hlh calibrator lots listed do not meet the stated expiration date claim. as a result, the quality control and patient sample results generated while using these calibrator lot numbers might be falsely elevated by as much as 13%. this can occur up to four months prior to the expiration date listed on the calibrator vial.
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
Manufacturer confirms that the automatic quality control (aqc) can be difficult to remove from the system, and will occasionally post a d33.2 valve error and fail to ejecy from the instrument. manufacturer advises the error is generated only during a failed ejection of the aqc cartridge. the issue appears to coincide with the recent introduction of the new return spring design for their aqc cartridge.
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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
Causa
An investigation has indcated that boxes of the specified lots of oxoid antimicrobial susceptibility testing (ast) discs may contain cartridges of a different ast product.
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 has confirmed a positive shift in patient medians of approximately 20% with the igf-1 assay. siemens has determined that an initial positive shift of approximately 15% occcurred with immuliate 2000/ immulite 2000 xpi and an additiional positive shift of approximately 5% was observed with immulite 2000/ immulite 2000 xpi leading to the total positive shift of approximately 20%., two potential health risks:, 1. could mask uncontrolled acromegaly and thus affect patient treatment., 2. could lead to an under estimation of hgh deficiency in children with borderline hgh deficiency and potentially result in missed or delayed opportunity to treat with hgh supplement.
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 has confirmed a positive shift in patient medians of approximately 20% with the igf-1 assay. siemens has determined that an initial positive shift of approximately 15% occcurred with immuliate 2000/ immulite 2000 xpi and an additiional positive shift of approximately 5% was observed with immulite 2000/ immulite 2000 xpi leading to the total positive shift of approximately 20%., two potential health risks:, 1. could mask uncontrolled acromegaly and thus affect patient treatment., 2. could lead to an under estimation of hgh deficiency in children with borderline hgh deficiency and potentially result in missed or delayed opportunity to treat with hgh supplement.
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
Manufacturer has identified a potential problem in two pulley drive components in the mixer pulley assemblies of the above - listed systems. in some cases pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. when these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
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
Manufacturer has identified a potential problem in two pulley drive components in the mixer pulley assemblies of the above - listed systems. in some cases pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. when these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.