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
Teleflex medical has been notified by their supplier of a premature "low sensor" indication on the internal oxygen sensor catalog number number #5804. the defect will prematurely indicate a "low sensor" causing the end user to conduct preventative maintenance earlier than earlier than necessary.
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
Software upgrade. this correction is a performance issue not related to patient or operator saftey.
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 identified through customer complaints a potential for leaking of cobas pcr media included in different kit lots of cobas pcr urine kits and cobas pcr female swabs sample 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
Baxter has received complaints for repeated system error 322 "link switch error (low)" occurrences with the sigma spectrum infusion system. this error may occur when there is a miscommunication with the two internal switches that detect door closure. if system error 322 occurs during infusion the sigma spectrum infusion system stops infusing. an audible alarm and visual alarm will also occur.
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
If the operator opens the parameter selection dialogue box after parameters have been selected for the ratio parameter the selected parameters could revert back to default choices.
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 has provided customers with an important product information notice regarding floseal hemostatic matrix. an update has been added to the precautionary statement of the instructions for use reminding users of the potential risk of inadvertent intravascular uptake of flowable hemostatic material particularly during surgical procedures which require exposure and opening of large or multiple veins (venous plexi). this may result in life-threatening thromboembolic events either at the time of application or in the post-operative period. patient positioning during surgery can result in low or negative venous pressure leading to hemostat introduction into the patient's blood stream.
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 cmvscan may exhibit weak reactivity when testing the low positive control that comes with 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
Siemens is notifying customers to discontinue use of dimension vista alkaline phosphatase calibrator (alp cal) kc330 lot 2ad052. siemens has received customer inquiries regarding correlation slope bias when comparing the dimension vista alp method to the dimension alp method. an internal investigation has confirmed that the activity of the dimension vista alp calibrator kc330 changes as the product ages and contributes to this correlation slope bias as well as accuracy shift.
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 observed that specific lots of the siemens aptt reagent dade actin fsl activated ptt reagent show an increase in heparin sensitivity over the shelf life. this increased heparin sensitivity prolongs the activated partial thromboplastin times (aptt) which may lead to a decision to decrease the anticoagulation dosage increasing the risk of thromboembolism.
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 results of the tensioning suture tensile testing were not consistent with previous accelerated shelf life 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
Beckman coulter has identified an issue regarding the response speed on the dxh system manager for unicel dxh 800 and 600 coulter cellular analysis systems that are connected to the proservice remote management system (rms). systems connected to the proservice remote management system (rms) that have not been rebooted after processing approximately 2000 patient samples will slow down and eventually terminate processes. patient results are 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
Sporadic field reports of intermittent failures with the safety vent valve test conducted during the power-up initialization and gave an electrical code #57 on the screen containing software revision c & b.
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
Stryker was aware of a labeling issue associated with the restoration modular plasma distal stem part # 6276-5-026 lot code # 20503201 and part # 6276-5-014 lot code # 20568201. the implant [part # 6276-5-026] was discovered with two different labels on the box. the box had the correct size #26 label at one end and a different size #14 label- part # 6276-5-014 lot code 20568201 at the other end. it was determined that there was a possibility that qty 1 of the size #14 may have a size #14 label at one end and a size #26 label at the other end.
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 stability of the rf latex calibrator odc0028 lot 0034 may be compromised and this lot of product may not meet its specified 13 month shelf-life (eg. results for patients and quality controls may rise to unacceptable levels over the coming months).
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
Revised control ranges for some of the analyte/instruments.
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 product is experiencing a fracture rate in which prior corrective actions have been ineffective in mitigating. in addition to recalling the product the manufacturer has ceased distribution of the subject 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
This reagent is demonstrating a positive bias in patient results. patient results which are greater than the upper limit of normal (30.2 u/ml) are biased on average 40% higher than previous lots. patient results which are less than the upper limit of normal (below 30.2 u/ml) are biased on average 55% higher than previous 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
A video showing how to perform maintenance was sent to 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
The on-board stability of reconstituted coagulation factor ix deficient plasma is less than the claims in the instrument reference guides.
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 version 3.60 du logiciel de d-10 serait susceptible de produire un resultat supplementaire en dupliquant le resultat de l'echantillon precedent avec l'identifiant de l'echantillon/numero d'injection (sample id./inj.#) suivant.
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
Is related to a possible increases recovery (positive offset of up to approximately 0.6 ng ml) in patient samples for thyroglobulin tg lot 169346. an elevated tg recovery may put certain patients (that had a total thyroid ablation) at risk of receiving (unnecessary) radio-iodine treatment for recurrent carcinoma or further (unnecessary) surgical intervention.
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
Side arm detached from the hub of the inner sheath in 2 cases.
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
Innacurate product labelling on reagent. the expiration date on the label states that it is to be used within 30 days of opening but the in reality it is acceptable for use within 60 days of opening. no calim of performance issue or harm to patients has occured.