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
N-acetyl cysteine (nac) when administered in therapeutic concentrations in excess of 500 mg/l (for the treatment of acetaminophen overdose) has been recently determined to interfere with assays for the following analytes: enzymatic creatinine osr6x204 cholesterol osr6x16 uric acid osr6x98 lactate osr6x93 and lipase osr6x30. only these assays are affected. nac is an anti-oxidant and can interfere with assays employing trinder chemical pathways i.E. where hydrogen peroxide (h2o2) is formed and subsequenly reacted with aminoantipyrine and an indicator in the presence of a peroxidase as a catalyst. nac interference has been demonstrated to occur to varying degrees depending on the analyte and therefore not all assays employing trinder chemical pathways are affected. nac interference may lead to falsely low 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
Beckman coulter customers reported that results for the estrone radioimmunoassay (ria) kit control i were reading higher than the confidence limits provided on the vial.
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 small percentage may remain occluded upon opening the roller clamp and may interrupt peritoneal dialysis treatment and require replacement of the transfer set.
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 that shaft of the type 01 elbow motor for exact arms used in the on-board imager (obi) device have failed due to belt over-tensioning.
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 recently received two reports that in four vials of contour embolization particles the actual particle size did not match the product's labeled particle size.
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
Hill-rom has become aware that certain progressa beds with integrated mattresses may have a potential issue during turn assist mode. an error code 31c9 may be displayed on the graphical user interface and the wrench light will turn on indicating service required. the 31c9 error means the turn assist bladder is unable to hold the required pressure to operate as intended.
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
Access afp qc kits contain three levels of control material identified as qc1 qc2 and qc3. beckman coulter has confirmed that vials of qc1 in certain kit lots contain microbial contamination.
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 exact couch and exact targeting couch for clinac or acuity units has the potential to trap a finger that could lead to loss of digit although some of the trapping zones (or pinch points) presented risks to lower extremities.
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
Ventilator display can freeze. when the dynamic lung is displayed an error in the internal graphics process can occur causing the display to freeze. the patient's ventilator continues but the screen is no longer updated and the user can no longer operate 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
To correct software error which could result in incorrectly labelled images.
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
Weak positive reaction in direct antiglobulin tests resulting in additional antibody testing by the 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
Salicylate results above 2.90 mmol/l may be negatively biased due to a non-linear response at the upper end of the reportable range.
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 the lots of aqc listed have been incorrectly value assigned resulting in a +0.8 g/dl bias for level 1 thb on rapidpoint 400/405/500 systems. some users are reporting higher than expected results for this aqc level. aqc thb levels 2 and 3 and all other aqc parameters are not affected.
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
Maquet/datascope has identified an uncharacteristic increase in the number of screen display related issues reported on the intra-aortic balloon pumps (iabp). the display controller assembly with date code 08_05 was defective and is associated with this issue. we are recalling iabp's manufactured with the display controller assembly date code 08_05. this issue may cause the iabp to exhibit display distortion 'pixeling' and blanking. although the iabp continues to deliver therapy to the patient these issues cause the user to be unable to read the information that is being displayed.
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 have been customer complaints for low recovery of qc and patient samples with specified lots. low patient results are due to troubleshooting following low recovery of qc.
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 tube portion of the sleev can separate from the button portion of the sleeve and remain in the patient. surgical intervention may be required to remove detached sleeves.
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 has identified a specific set of system serial numbers that may have been manufactured with a card guide that has an extra lock washer.The extra washer is not necessary when assembling the card guide and may lead to damage of the electronic chassis components. if one of these components fails the system will become inoperable and stop sample processing.
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
Electrostatic energy may be stored in systems that can cause a short-circuit which in tun can generate an electomagnetic pulse which might disturb the electronics of the digital motion control board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or patient.
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
La charge microbienne de certaines fioles de l'anticorps monoclonal hsv de type 1 du lot 927277 contenues dans la trousse pouvaient ne pas respecter les normes de fabrication.
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
Ifu does not contain instructions how to reassemble the torque wrench after reprocessing.
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 has been an increase in the number of unexpected positive thc 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
The body fluids rbc (red blood cells) parameter may fail to meet limit of blank (lob) limit of detection (lod) and limit of quantitation (loq) specifications and the body fluids tnc (total nucleated cell count) parameter may fail to meet limit of blank (lob) specifications on the unicel dxh 800 and 600 coulter cellular analysis 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.