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 advises that the lots specified show imprecision for hba1c patient results. the storage stability data shows a deviation in the range of -10% up to -30% from the target value with an error rate of up to 40%. no deviation was found with previous lots.
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
Philips received a report from the field that the fpd failed to remain securely latched in the stowed position., a system warning message appeared warning the user that the fpd was unlatched. by design, the unlatching of the fpd caused the system to activate the e-stop. in an attempt by the operator to clear the warning message while in the 0 degree position, the fpd released from the stowed position.
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: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
Causa
Fisher & paykel healthcare (fph) has become aware that the rt008 entrainers with lot number 130726 may potentially be difficult to rotate. our risk evaluation identified no safety risk for this issue. however, it can potentially cause user inconvenience and a replacement may be required.
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 incorrect assembly may result in the analyser not being able to read the contents of the memory chip in the solution pack when installing the pack. if the chip is faulty, the analyser will express an error.
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 Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
An investigation identified a defect in the production process which can lead to occlusion of the irrigation fluid lumen. to date, there have been no patient injuries or adverse events reported as a result of this defect.
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 Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
An investigation identified a defect in the production process which can lead to occlusion of the irrigation fluid lumen. to date, there have been no patient injuries or adverse events reported as a result of this defect.
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
Under certain conditions, x-ray release on artis system version vc1x may get blocked. this potential malfunction will only occur if a) the system is ready for operation, and b) the c-arm was moved into the “patient transfer position” for patient transfer (in this position x-ray is blocked), and c) at the same time the c-arm is in “patient transfer position”, a hardware failure in the image acquisition system is occurring. even if the c-arm is moved out of the “patient transfer position” (the problem with the ias was solved by the system itself), x-ray remains blocked.
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: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
Causa
The manufacturer has received reports of an increased rate of intermediate-reactive barmah forest igm results in patients who do not go on to seroconvert i.E. false-positive results. asymptomatic blood donor samples are consistently non-reactive and convalescent samples from confirmed seroconverted patients are consistently highly reactive.
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.
Upon review of the qa release testing, the range that was calculated at the time of kit release was calculated per standard operating procedures and supports the positive control range that was assigned upon release of 2.2-4.1., however, upon investigation of history (as a positive control in several kit lots) and additional testing it has been re-evaluated and determined that this range requires an adjustment to 2.2-4.6., if you have used this kit lot to test and report patient results, and the positive control was within the assigned range (2.2-4.1), then the reported patient results were valid.
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: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
Causa
Covidien has updated the instructions for use for polyurethane single lumen umbilical vessel catheters to include additional information on the care of the device. the updates were made to address the increasing use of disinfectants containing alcohol and/or acetone to clean vascular access devices. while the manufacturer recognizes that these materials are now required in many hospital protocols for routine cleaning of vascular access devices, the use of these disinfectants can cause damage to the polyurethane contained in the catheter and make it more susceptible to physical damage, which may ultimately lead to the need to replace the catheter.
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: Grifols Australia Pty Limited, 5/80 Fairbank Road, Clayton South, VIC 3169, AUSTRALIA
Causa
The manufacturer advises that some cards are incompletely sealed. in affected cards this will induce deterioration of the card presentation, resulting in some microwells showing evaporation of the supernatant. this phenomenon can be observed as either a reduction in the gel level or the appearance of cracked gel.
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.
Stryker has become aware of a risk that with excessive force, there is potential for a mounted monitor to be lifted out of the yoke of the vision mounting arm during positioning. this has the potential to cause injury.
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
Non-compliant resistance (to the tension of the knot and to the detachment of the needle).
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 post-market surveillance activities, siemens has determined that not all distributed lots would meet the performance criteria as currently described in the instructions for use (ifu) with respect to analytical sensitivity (i.E. 1.15 iu/ml).
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 advises that users can inadvertently enter a wrong patient id on the demographics screen, which ultimately could lead to a misidentification of the sample.
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.
Stryker has received reports that the hex tip of the xia 3 torque wrenches of an identified lot number subset have been fracturing during final tightening. the hex tip of the wrench is broken off and separated from the main tube.
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.
Stryker has received reports that the hex tip of the xia 3 torque wrenches of an identified lot number subset have been fracturing during final tightening. the hex tip of the wrench is broken off and separated from the main tube.
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 indicates that specific lots of check valves used in several locations with the lh750 and lh780 analysers may fail. this failure may result in an air or liquid leak at the connection to the vacuum overflow tank waste line or at the backwash tank drain line.
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 indicates that specific lots of check valves used in several locations with the lh750 and lh780 analysers may fail. this failure may result in an air or liquid leak at the connection to the vacuum overflow tank waste line or at the backwash tank drain line.