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 the stability study of a new batch of zym b reagent (70493) a visual defect has been observed. after three months of stability this batch presents an heterogeneous aspect of color from yellow to red (a color yellow to amber is considered as conform according to the package insert). this visual defect is due to a specific new batch of raw material (lot mkbp5202v of fast blue bb salt sigma) used for the manufacturing of several batches of fb reagent and zym b reagent. as the involved batches of zym b reagent are included inside of api nh (10400) and api listeria (10300) kits the both references are also impacted.
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
This lot may contain a small number of test modules that are missing conjugate solution and will give llcnsig or blwl errors for test modules that does not contain conjugate.
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
Incorrectly assembled instruction manual as the manual contents for the model lf-2 was put into the manual for the model lf-2 and vice versa.
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
Certain specific lot may have potential defect in the proximal shaft and strain relief.
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
Zimmer biomet is conducting a lot specific medical device field action for comprehensive reverse shoulder trays manufactured prior to september 2011 due to a higher than anticipated rate of fracturing. devices manufactured after this date have design enhancements that increased the strength 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.
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 is a potential for erroneously high platelet (plt) rbc mpv and hematocrit (hct) results to be generated. the erroneous results may occur on the first aspiration of a tube and may occur without instrument generated messages. testing has demonstrated an average probability of occurrence of erroneous elevated platelet counts on the first aspiration of a specimen tube of 0.6% with a 95% confidence interval of 0.21% to 0.99%.
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 a client complaint intelerad has identified a software defect which could lead radiologists to base their diagnosis/report on wrong anatomical measurements.
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
A potetial packaging issue has been identified with the primary pack of the guardian device. during transport testing of a new kit packaging integrity failures were identified.
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
Bd suspects that there might be increase in clogs due to coring that result in an increased frequency of inadequate sample dispensing.
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
Inability to obtain a valid calibration curve due to a shortened a-f span because of insufficient yeast alcohol dehydrogenase enzyme (yadh) in the t-reagent bottle.
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
Solta medical is conducting a voluntary recall of the vaser amplifier that were returned to the solta bothell washington service depot for repair between september 8/2016 and may 23/2017 due to the potential that the device was inaccurately tuned by the service depot during repair. the use a product in the affected range constitutes a potential risk and could contribute to burns.
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
Boston scientific has discovered an inconsistent "use by" expiration date on a single lot/batch of alair bronchial thermoplasty catheters. the expiration date is listed in two locations on the packaging of the productthe outer box label and the inner tray label. the expiration date on the outer box label 2014-04 is correct. however the expiration date on the inner tray 2012-04 is incorrect.
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
Failures occuring in batteries that have been used longer than the expected tw0-year 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
Recall initiated following reports from customers where patients who recently switched from the current shiley neonatal and pediatric products to the affected products experienced discomfort immediatly after the switch in a limited number of situations. in some cases breathing difficulties corresponding to a negative effect on oxygen levels were also observed immediatly after the switch.
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
Masimo has identified a small number of pulse oximetry cables that were mis-wired resulting in inaccurate spo2 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
Ecg and respiration signal noise caused by dash pdm and/or tram ecg cable connector movement may result in reduced ecg respiration and arrhythmia detection performance.
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 pump uses an optical sensor to detect the presence of fluid or air in the administration set which is why at the completion of a feeding it is expected that the pump will alarm as outlined above. however residual clumps from certain types of feeding preparations may be interpreted by the sensor as food remaining in the administration set causing the pump to continue to run despite the bag being empty. this situation likely occurs with home blended or prepared food as well as non-traditional additives such as fortifiers lipids proteins etc. if the sensor is obstructed by sticky solids it may cause the pump to continue running and cause an overrun failure and may potentially deliver air to the users.
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
On may 12 2006 product advisory was iisued regarding potential for device malfunction in certain icd and crt-d when implanted subpectorally with serial number facing the ribs.Vitality models are added to 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
Reassesment of the functional sensitivity of cortisol elecsys cat number 11875116122 all lots. the currently claimed functional sensitivity of 2nmol/l as given in the package insert not supported.
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
Cardinal health has received communication from degania silicone of a recall they have initiated on one lot of jackson-pratt drain due to missing labels on the units.
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 corrosion or nuts to crack on rw6000 helium compressor.