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 the possibility that during stitching on the table a failure occurs and the last single image is not available. in this case a retake is necessary. there is the possibility that line artefacts will be visible at the edge of the x-ray image when using the skyplate detector.
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 recall has been initiated by the manufacturer for their innova units in order to send updated operator's manuals to the end users. there is no safety issue related to this recall and the units can continue to be used.
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 absolute count recovery failure and fluorescent populations containing more than 20% of the total population.
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 sterile barrier has been compromised on the electrosurgical pencil electrodes.
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
When using f12 key to mark patient study as completed a different report for a different study is being assigned to that study. when f12 pressed before report palette updated with selected study info.
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 displayed values in the cca application for the extended brilliance workspace should be labeled as being the percentage of increase in the wall thickness between the end diastolic and the end systolic states but what is actually being displayed is the decrease in wall thickness from the end systolic to the end diastolic state.
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
Interlink system micro-infusion manifolds that are connected together in series may loosen or disconnect at the luer connection if the manifolds are twisted in an attempt to align the interlink ports after the luer connectors have been tightened. loosening or disconnection may result in a leak.
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
All units are to be refurbished. includes replacing motor support bracket and correction of uncontrolled movement of the system.
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
Vital diagnostics has recently informed us that the lot and product mentioned above did not go through the irradiation process as required. the manufacturer irradiates the tubes in an effort to reduce 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
A decrease in potency of the polyclonal anti-c component of the abs qc antibody during storage.
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 directions for use will be revised to include the following information: -clarification that the acrysof cachet phakic lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d. -additional information regarding the risk of early acute endothelial cell loss (ecl) to strengthen communication of benefits and risks of implantation to the patient. -clarification on the frequency of monitoring for ecl by specular microscopy. the new recommendation is applicable for post-operative follow-up at one month three months and six months and then at six-month intervals in collaboration with the treating physician. -data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm2 in the clinical studies.
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 has determined that the above product exhibits decreased fluorescence when testing with homologous control organism. as noted in the package insert controls must be performed with each test series.
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
In kits of a*01 lots 41v 35x and 83y the a*01:04n allele is not amplified by primer-mix 5 as stated in product documentation. the false negative amplification for the a*01 kit yields a revised reactivity pattern for the a*01:04n allele that is identical to a*01:01 alleles.
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 primer mix in lane 6 (primer mix r13-51b) of the affected products may cause a drb1*13:50 allele to be typed as a drb1*13:14 allele. these alleles occur very rarely. this issue is due to limited sequence information available for this allele at the time of release. due to the recent availability of a sample exhibiting the drb1*13:50 allele a new lot-specific comment has been added to the quality control comments alerting users to the possbility of a false negative in lane 6 with the drb1*13:50 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.
Notas adicionales en la data
Causa
The repair connector can disconnect from the extension tubing which could lead to blood loss.
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 aaa backup battery packs may have been wired incorrectly. this wiring issue causes an error code to be displayed and results in the device repeatedly sounding alarms at power up.
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
Probe may drip diluted bleach as it moves over to the back reagent rack. this could result in contamination of samples leading to incorrect results when samples are analyzed.
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
Qc may not be reset after reported qc failure. this occurs because qc passed but was repeated and failed prior to the 24-hour expiration period established for the first 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.
Notas adicionales en la data
Causa
The problem was identified through the supplier's internal quality system on a production lot. at issue is the lack of an adequate silicone seal around the periphery of the attenuator enclosure which houses an in-line series of resistors designed to restrict the level of energy being transmitted to a pediatric recipient during defibrillation.
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 voluntary recall is being conducted due to a labeling error. the label indicates the product is latex-free however the headband component included with the forehead sensor does contain latex.
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 have received customer reports of arcing/sparking on the defibrillation electrode leadwire. covidien was also aware that the wire/connector subassembly supplier experienced equipment damage due to misalignment from installed tooling. this could r4sult in arcing sparking or thermal damage to the leadwire which could render the device incapable of delivering the appropriate energy or shock to the 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.
Notas adicionales en la data
Causa
Ortho clinical diagnostics (ocd) has identified an anomaly with vitros system software version 3.1. internal testing confirmed that when using calibrator barcode labels supplied with vitros chemistry products calibrator kit 2 calibration may not occur under specific circumstances. consignees are being advised not to use the calibrator barcode labels for vitros calibrator kit 2 until this anomaly is resolved in a future version of software.