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 reagent transfer (ed assembly) probe aspiration height was adjusted during a service visit to a value below the acceptable range for the aspiration height (116.45 - 116.95 mm) on one pk7300 device in 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
Stryker has become aware that the directions for use (dfu) shipped with the target coils references target coil products have not yet been approved in 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
Shorting of the battery resulting in depletion during a relatively short time period.
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 bolt that fixes the monitor ceiling suspension to the ceiling mount may come loose causing the monitor ceiling suspension to fall down.
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
Advisory letter recarding use of calcium scoring task cards -- see main screen.
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 testing of retention samples for heparin potency some lots failed anti-factor iia assay for potency. these syringes do not meet the usp monograph requirement for potency.
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
Covidien is conducting a voluntary field correction with updated labelling to clarify the operational life of the oxygen sensor (o2 sensor) p/n 4-072214-00 used in the puritan bennett 840 ventilator and p/n g-062010-00 used in puritan bennett 700 series ventilators (puritan bennett 740 and 760 ventilators).
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 corporation is issuing a recall for specific lots of buretrol solution set product codes due to complaints for separation between the burette chamber and the drip chamber. the root cause for this issue has been identified and resolved.
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
During the manufacturing process the sodium high calibrator value was incorrectly assigned for the rapidpoint 500 measurement cartridge (specified serial number range only) causing a negative bias on both qc and patient samples. cartridges within the specified range but marked with a green dot on the box and/or catrtridge 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.
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 software issue that may affect results from diluted samples run on the vitros eci immunodiagnostic system tested with the vitros immunodiagnostics products total beta-hcg ii reagent pack. ocd has received complaints of observed results from diluted samples that were reported as <2.39 miu/ml (iu/l) instead of the correct 'no result' which is accompanied by an invalid dilution (id) code. the diluted results were inconsistent with results from the neat (undiluted) sample which was within the measuring range of 2.39-15000 miu/ml.
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 received complaints of positive shift of patient and qc results when the alti assay is calibrated with specific lots of dimension enzyme ii calibrator. internal investigation has confirmed that patients quality control and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. the shift began with lot 4md047.
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 leaking stopcock spare part (922640 rev.02) used in the autostainer isntrument family has been obersved. feedback from service engineers indicate that the stopcock component of the syringe assembly is leaking around the plunger in the stopcock when the prove is being washed/flushed. this could result in a reduced intensity score giving a false negative result in harceptest but does not affect the clinical outcome of any other reagents.
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 fume test has been conducted and set-up to measure the emission of formaldehyde from the artisan instrument. results for the fume test showed that the emission of formaldehyde exceeds the threshold limits set by the following provinces in canada: manitoba newfoundland & labrador nova scotia prince edward island.
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
Four customer complaints were received for one lot of ar176 artisan grocott's methenamine silver (gms) stain kit regarding fungal looking organisms appearing after staining particularly on the periphery of slides away from the stained tissue. the contaminate was confirmed to be fungal most likely common indoor mold wallemia sebi and was confined to one reagent supplied by an outside vendor. artisan grocott's methenamine silver (gms) stain kit is indicated for identifying fungal organisms including pneumocystis jirovecii. the contamination could potentially compromise the device's diagnostic effectiveness.
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
Discoloration of the acetaminophen enzyme reagent (r1) has been observed in some cartridges of lot 41928uq11. the discolored reagent generates a high calibration factor and erratic control recovery and may result in both high and low acetaminophen patient 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
An incomplete seal of the package compromises the sterility of the 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
Tears: through standard product quality testing it was noted that the adhesive labels intended to keep the drape folded were found in some instance unintentionally overlapping multiple folds of the drape. cloudy/waxy appearance: through customer feedback intuitive surgical found that some of the drapes used with the da vinci systems may exhibit a cloudy/waxy appearance.
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 confirmed a negative bias against the mean values obtained with the lgcocm control lot 0026 level 2 when used with immulite/immulite 1000 igf-1 (lkgf1) kit lots 322 and above. also confirmed is an increase of mean values obtained with the lgcocm control lots 0025 025l & 0026 when used with immulite 2000/immulite 2000 xpi igf-1 (l2kgf2) kit lots 486 and 487.
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 a follow-up correction zimmer biomet is removing from the field a subset (from zimmer gmbh) of highly polished implants that were packaged in a low density polyethylene (ldpe) bag with a potential to adhere to the implants. in september 2013 customers were asked to examine devices before use and return any showing signs of ldpe adhesion. at that time a new bag was introduced that resolves the issue and prevents the bag from adhering to the implants.
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 interfaced via a 9015 cable to an external data collection device a 9004 monitor configured with ccap 1.13 software will not communicate reliably through either channel 3 or 4. this issue only occurs when the monitor's analog output is set to external.
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 testosterone reagent kits have included document a82247a ("kit stuffer") since december 2009. the kit stuffer incorrectly states that unicel dxc600i instruments are not implicated in a product corrective action regarding reagent contamination. dxc600i customers were informed of the reagent contamination issue in october 2007 in a recall letter (pca-c-e-1051) but the specific reference to the dxc600i instrument was inadvertently omitted from the testosterone kit stuffer.
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
Potential for breakage of device. the manufacturng process utilizes a two-piece construction which is a concern due to the type of application where the impaction stresses are high.