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 increase of complaints was observed regarding bent or broken drive pins of the validation tool manufactured with drawing revision m to p.
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 guide rail of the defective holder is 10 mm shorter than normal. this prevents the head holder from properly locking into place causing possible injury to the patient's head.
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 stated in the codman programmable valve ifu the virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm h2o. recent in-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm h2o. this may result in a delay in treatment for shunt-related complications.
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
After installation of lx software 4.5 pre-existing user defined reagent (udr) cannot be updated.
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
Immage igg lot m610132a parameter card barcode does not include the "a" suffix encoded in the barcode. the reagent cartridge barcode needed to pair with the parameter card includes the "a" suffix. lot number mismatch causes a "parameters not found" error upon reagent cartridge barcode read. input of parameters and reagent load is by barcode only. system is not capable of manual entry.
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 item is being recalled due to an inadequate pouch seal. this defect has the potential to lead to a loss of sterile pouch integrity which could impact the product's sterility assurance and may lead to serious adverse events such as infections both localized and systemic.
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 of the device does not hold device licence in respect with the root-cal. / le fabricant n'est pas titulaire d'une homologation pour le root-cal.
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 has issued an important product information communication to advise customers regarding changes that are being made to instructions for use (ifu) for various baxter pd (peritoneal dialysis) transfer set product codes. baxter is updating these ifus to improve product labeling and ensure consistency of information across the baxter transfer set product family. see also recall number 82893.
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 is providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifus). the current advia chemistry systems lactate dehydrogenase ifus intended use section contains the following statements which will be removed: advia chemistry ldlp: they may also be used to monitor cancer therapy. advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy. the revised ifu intended use for both assays are listed below: advia chemistry ldlp: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction. advia chemistry ldpl: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction.
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
Analytical studies showed that the nuclisens easyq enterovirus kit can not detect enterovirus serotype 68 and rhinovirus serotype 87. therefore biomerieux revised the instruction for use of nuclisens easyq enterovirus products in order to remove these serotypes from the list of the serotypes detected by the kit.
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
To correct a number of performance problems unrelated to safety.
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 result flags can result on printed reports and screen displays in rare circumstances.
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
Carestream has identified an incorrect orientation of the indicator dot on dental intraoral film packet labeling of some lots of insight item 811 0785 (size 0 packet) ib-01 and some lots of ultra-speed item 834 8658 (size 0 packet) df-48. the indicator dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. this issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. the result is the image orientation will be rotated 180 degrees. the remaining content on the label is correct. image quality is not 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
A wire in the connector of the generator grid switch supervisor box in each device might become short-circuited between 12v power and ground causing a system breakdown.
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
Use of the affected products may cause the mis-identification of certain organisms typically identified by these kits.
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
Manufacturer has received complaints of prolonged clotting times with freshly reconstituted reagent and/or shortened clotting times with reagent stored at 2-8 degrees c after reconstitution.
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
Following internal investigation of a customer complaint the manufacturer identified a situation where the cobas 8100 system reformatter module brf sw version 02-xx may cause sample racks crash potentially leading to be shaken and specimen to be spilled. there could be an impact on the test performance since a cross-contamination cannot be excluded and could lead to erroneous results. the manufacturer advised us of this on 20-feb-2017.
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
Decrease in creatinine concentration in mcc may result in an upward shift of creatinine results of up to 12%.
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 approximatly 9% negative bias in patient results and total t4 low (l) and medium (m) controls have the potential to read below the package insert specifications.
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
It has been confirmed that there is a potentially incomplete seal in the pouch.
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
Replacement of pc 104 board on the motor controller.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
Potential for false air-in-line alarms when initiating iron sucrose infusions at concentrations between 0.7 mg/ml and 2.8 mg/ml.
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 on-board stability issue was identifed with the 8 ml size of hemosil recombiplastin 2g. the stability claim has been reduced to 3 days for all current and future product lots of this product.
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
Two customers have observed values that are not concordant with the expected values published in the insert while performing evaluation testing.
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
Vials of affected lot numbers contain less than the labeled amount (1cc) of particles.