Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
During quality control and improvement process for visage 7 software two of specialized 2d measurement tools in some situations do not allow for manual pixel calibration and can lead to misleading results.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
There can be a sporadic seal failure in the chevron seal portion of the pouch on some products causing the product to be non-sterile.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Ortho confirmed that results obtained from vitros ipth reagent packs are positively biased (i.E. falsely elevated) compared to an alternative commercially available method. ortho observed a positive bias of 40% for samples with ipth concentrations <100pg/ml when testing with vitros ipth reagent packs in comparison to the roche elecsys pth test. ortho data demonstrated that this bias was consistent for all in-date lots.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The depuy synthes button plate(s) were distributed with a package insert containing incorrect mr safety information that does not meet the current astm standard. in 2008 standard method astm f2503 standard practice for marking medical devices and other items for safety in the magnetic resonance environment was revised. the synthes button plate was labelled as mr safe per the astm standard metallic devices are no longer identified as mr safe.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Removal of product from distribution that exhibits possible vacuum/suction leaks. the leak is attributed to incomplete bond between the chest barb connection and the guide tube.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Associated product technical bulletin mp-12-077 meets the canadian medical devices regulations definition for recall.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
A software bug has been identified where 248.5513 days after being switched on the thermo scientific excelsior as software switches from a positive to a negative count cycle.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Affected units may have a bearing malfunction that can cause inaccurate delivery of fluid including back flow over infusion and/or free flow. the pump may not issue an alarm when this occurs.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Ortho clinical diagnostics (ocd) internal testing has confirmed instances where vitros 51 fs 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen regardless of the pretreatment requirements for each selected assay potentially leading to biased patient results. urine samples for use with vitros ca mg and phos slides require acidification (pretreatment). the engen system software currently does not route these samples to the manual high priority exit location for pretreatment as intended. in addition the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pretreatment. depending upon the assay urine samples need to be acidified alkalized extracted or not treated prior to being processed on vitros systems.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Integra lifesciences corporation (integra) has recently become aware that the current packaging configuration for the non-sterile step down connector may lead to a potentially conflicting message regarding product sterility. this individually sold non-sterile stepdown connector is packaged with a label that correctly states the product is non-sterile and also with instructions for use (ifu) from the sterile kit with which it is designed to be used as a reference to the customers. although the accessories are marked on the external label as non-sterile the ifu which is visible through the packaging states that the related shunt kit is sterile. this may lead to confusion as to whether these non-sterile products are sterile.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Through internal investigation medtronic has identified the potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
They received and confirmed one report that thephenotype of the cells in vial #5 (untreated) were the same as the cells in vial #4 (untreated).
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Erroneous results may occur as a result of a software issue when specific conditions occur with the phadia 250. the issue can occur with all versions of the phadia prime software up to and including version 2.1.4. the issue will cause software to disregard default dilution factors for rejected samples when using the "ok to all" function for retesting of samples if specific criteria are met.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has confirmed that control vlaues prot1 con h may be found out of range ( >+/- 15%) for dimension vista prealb flex reagent cartridge leading to invalid runs. we have no indication that other analytes in prot1 con h are affected by this issue.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Outer pouch may not be completely sealed below the pouch thumbnotch area thereby potentially compromising the sterility of the device.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Specific lot numbers of the .050 one-piece hex driver (135-351) may not engage properly. this may make it difficult to tighten or loosen compatible biohorizons components such as abutment screws coping screws and healing abutments.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Potential for missing segments on the meter lcd display which could cause blood glucose results to be misinterpreted.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The puncture of the distal tube by the mandrill which is not completely inserted in the catheter.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Potential for intermittent cracks in the raw material batch used to produce the affected products.The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Baxter corporation is initiating a product recall for one (1) specific serial number of homechoice pro automated pd system because of a shipping/receiving error at baxter's third party logistics provider that led to an unreleased device being shipped to one (1) customer.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
A potential leak in the breathing system under specific circumstances in which the seal on the main system manifold becomes unseated.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Potential for excess material to separate from catheter during procedure.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Reports of unexplained elevations in patient results.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Potential that customers running the magnesium rtu assay on the abx pentra 400 chemistry analyzers that on-board stability has been updated. user will be unable to calibrate the magnesium rtu assay after 1 day of on-board (on instrument use) the control will be out of range at values lower than target values. the result reported using this failed calibration will be flagged "cal_error" displayed on the results with a "c".