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
Smith & nephew has received several reports of cases in which the trigen meta semi-extended drill guide had broken during use. the guides may break at the weld during nail insertion preventing the use of the meta nail drop.
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
Warnings in manual conflict with sections in the manual. potential for mechanical and voltage hazards during maintenance.
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 increase in size of the opening on top has allowed the possibility of the wash buffer bladder to be pulled out higher than it should be.
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
Error on the assay in the level 4 platelet value for the beckman coulter maxm instrument(only). the assay contains an undiluted value but should list the diluted value of 910 +/- 150.
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
Mislabelled packages of the k3 gutta percha .04/20 points (part number 825-0420) contained the k3 gutta percha .04/40.
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
Cleaning/disinfection/sterilization instructions are inadequate or insufficient. manufacturer issued an advisory to all customers until new cleaning/disinfecting instructions are available.
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
Immucor inc. (manufacturer of the device) notified dominion biologicals limited of the intent to initiate a market withdrawal of cell 4 included in the panocell-10 ficin-treated lot 38324-e. cell 4 (donord1377) on this panel is listed as s+s- on the master list. in response to a report of unexpected negative reactivity on untreated cell 4 we have reproduced the customer's reported results. cell 4 has demonstrated reactivity varying from negative to 3+ using different sources of anti-s. cell 4 is one of four s+ red blood cells on this panel: cells 2 7 and 9 are also s+. cell 4 is the only s+s- cell on this panel.
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
Received complaints of dark stain under product when temporary crown was removed and that product did not 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
The lifepak 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (relay) installed on the therapy printed circuit board assembly (pcba). a malfunction of the relay can be identified during the user test of the device as described in the chapter titled "maintaining the equipment" within the lifepak 15 operating instructions.
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
For a specific number of artis zee/q biplane systems a screw connection in the ceiling mount consisting of 12 screws might not have been attached and fastened according to the quality standards. the connection is located within the rotation unit of the second plane.
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
One complaint regarding this issue has been received. complaint states the b*35 aiiset gold ssp kit has a false negative in lane 8 which gives no perfect match typing result for the b*35:116 allele. internal investigation has confirmed with the now available rare sample type that lane 8 is negative for the b*35: 116 allele in the above listed affected kits according to the labeling provided with the kits. the primer mixes had not been tested with a b*35: 116 sample the labeling stated the primers in lane 8 would amplify the targeted sequences in the b*35: 116 allele.
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
Lot numbers exhibit a positive bias with quality controls and patient results (average about +20%).
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 package insert that accompanies qualicheck qc reagents used with abl 70/77/555 analyzers listed incorrect control ranges for hematocrit testing. the stated range was too low to generate accurate 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
A contaminant fungas of the polymer ap was found during an internal qc testing. the fungal contaminant could potentially cause a loss of staining sensitivity and/or an obstruction to fluid delivery to the slide.
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 id providing guidance regarding sample pretreatment steps and to revise the protein interference information in the package insert.
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 are two inaccuracies that exist in the advia centaur cp operator's guide appendix d pre-set tube types. the first refers to the sample volume supported by the system when using the ezee-nest cup to process samples. the operator's guide states that sample volumes greater than 50 ul can be used however volumes greater than 150 ul cannot be used when using an ezee-nest insert cup. the second refers to the use of the universal cup adaptor with an ezee-nest insert cup in 65-mm sample racks. siemens has determined that the height of an ezee-nest insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. no samples will be processed.
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 confirmed customer reports of high y-glutamyl transferase (ggt) recovery on patient samples and quality control material using ggt lot m107333. samples recovering within the ggt reference interval recovered approximately 13iu/l 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
Issue related to an e-10 time/date error that under rare circumstances could potentially cause incorrect bolus advice on the accu-chek connect diabetes management app.
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
Complaints were received for the same batch of v40 lfit vitallium femoral heads (part number 6260-9-032 lot 48681201) alleging that the femoral head could not be assembled with its corresponding v40 stem trunnion.
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
Some of the outer trays used in the packaging of the products were found to have cracks. therefore the packaging may have been compromised and sterility of the product cannot be guaranted.
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 a manual dilution is ordered in the "batch tests by rack screen" the software will not accurately calculate the result and the final result will not be correct.