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
Possibility of operator pinching their finger between the fixed roller and the gliding tabletop.
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
An increased number of unconfirmed positive bzo incidents since the vendor changed antibodies.
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
Les engrenages situes entre le moteur et la vis sans fin de la colonne de levage peuvent se briser suite a un defaut de plastique fragile.
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
Bio-rad avise les utilisateurs des lots de variant ii turbo hemoglobin a1c program reorder packs qu'ils doivent s'assurer que la ligne de base des chromatogrammes ne presente pas une pente ascendante. la possibilite existe que soit sous estimee la concentration d'a1c de certains echantillons.
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 rapidqc complete solution level 2 lot numbers 362601 362602 362603 and 362701 contain an incorrect value assignment (target and range) for both glucose and lactate.
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
La defectuosite de la carte est telle que le programme ne pourrait pas fonctionner. l'appareil ne pourrait pas analyser des hemoglobines a2 avec un programme destine a l'hemoglobine glyquee a1c.
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
Certains lots pourraient presenter des reactions atypiques ou faussement positives principalement lorsque des eluats ou des controles sont testes moins frequemment lorsque des echantillons de patients le sont.
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
Abo cards containing anti-b clone g1/2 displayed weaker reactivity at the end of the shelf life.
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
Whole blood samples (either fresh or frozen) for hba1c testing are pre-treated with multigent hemoglobin denaturant. the pre-treated samples are placed on the architect systems and tested for glycated hemoglobin (hba1c) and total hemoglobin (thb) concentrations. according to the package insert pretreated samples must be allowed to incubate for a minimum of 5 minutes at 15 to 30 degrees celcius prior to testing. pretreated samples are stated to be stable for "up to 8 hours at 15 to 30 degrees celcius and up to 48 hours if stored at 2 to 8 degrees celcius". however recent studies have demonstrated that hba1c measurements increase with time after the samples are pre-treated. therefore it is necessary to change the handling instructions for pre-treating samples for the multigent hba1c assay. the investigation to determine root cause is ongoing.
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
As of december 31 2012 sorin has confirmed 30 instances out of 13500 units implanted worldwide (0.222%) where the analysis of the returned leads identified internal insulation breach under the right ventricular (rv) and/or superior vena cava (svc) defibrillation coil electrode resulting in low pacing impedance and/or ventricular oversensing and/or inappropriate therapies. no permanent serious injury or death has been reported as a result of the confirmed malfunction.
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
The alcon acrysof cachet phakic lens is a uv-absorbing anterior chamber meniscus lens designed to provide refractive correction in the treatment of moderate to high myopia. alcon has updated the directions for use (dfu) for the alcon acrysof cachet phakic lens.
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 problem could occur where user may calibrate collimator angle position readout in reverse switching the 90 degree and 270 degree positions. this could cause patient treatment with the wrong collimator angle for any collimator angle other than 0 degrees iec. a reversed calibration could cause any attempt to perform a remote auto motion of the collimator to result in a failure to reach the target position. in this case the collimator would rotate in the direction opposite the proper direction to reach the target angle and would reach the mechanical limit before reaching the target angle.
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
Select arterial line catheter and introducer kits manufactured by argon medical devices inc. contained in specific lots may exhibit a potential defect with the outer tray. the defect may or may not be noticeable to the user. the outer tray issue may compromise the sterile barrier.
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 integrated cassette volume check (icvc) is not automatically performed on the cobas 80000-c502 chemistry analyzer for the cobas c pack multi and for the carbamazepine carb3 for c311 and c501/502 due to icvc being deactivated in the rec file for these reagents.
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 manufacturer has advised of an issue with the product setting faster than specified in the directions for use.
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
Catheter may have an assembly error.Manufacturing doc was ambiguous.
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
Positive bias of approximately 0.1 ph unit on the nova 8 analyzer which can cause higher than expected calculated normalized calcium and calculated normalized magnesium recovery values.
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
Gram-negative organisms do not grow on the macconkey agar side of the bi-plate.