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
Platelet counts were produced for thalassemia & idopathic thrombocytopenic purpura were significantly higher that estimates for plt counts and upper region interference flag by the instrument.
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
Ocd has received customer complaints of a downward drift/shift in quality control results or low quality control results when using vitros chemistry products cocm reagent. this drift/shift will likely be observed within approximately 3-14 days of calibration. patient results may be affected in the same manner. our investigation has shown that recalibration will be initially effective in resolving the issue but that increased calibration frequency may no longer be effective over time. ocd internal testing has confirmed that this issue occurs will all lots of vitros cocm reagent that are within expiration dating. as a result customers are being asked to discontinue using and discard all vitros cocm reagent remaining in their inventory.
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 diagnostic (ocd) has received complaints of the inability to calibrate the vitros? chemistry products hpt reagent. ocd has also received reports of an increase in u91-274 condition codes. although all affected lots met all release testing specifications prior to distribution an ocd investigation has confirmed an increased occurrence of condition codes and calibration failures when using these lots over a period of time. ocd testing has found that as the reagent ages a potential for biased results exists if you are able to obtain a valid calibration.
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
Due to handles requiring batteries to operate it was determined the potential for insufficient contact causing inconsistent (intermittent or flickering) lighting was present for a small number of the handles. intermittent lighting may compromise the user's ability to visualise the patient's airway which may result in delayed treatment.
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
15 boxes containing curix ultra uvl plus were mislabeled with cronex 10t.
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
Zimmer gmbh is initiating a recall by issuing a revised instructions for use (ifu) for the biolox option ceramic femoral head system sizes 28mm to 40mm. zimmer determined that the current information as described in the ifu and in the design rational document was confusing. the system offers the option to treat primary and revision cases. in hip revision surgery the original stem could remain in situ. for this specific scenario the biolox option ifu and the design rationale document related to the heads have been revised to improve the definition for the level of allowed damage for the stem taper.
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 medical has recently updated the instructions for use [ifu] for the intouch critical care beds.
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
Dust/locking cap has been omitted from certain ranges.
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 drb1*04 ssp unitray kit has a false negative in lane 9 which gives no perfect match typing result for the drb1 *04:32 allele. internal investigation has confirmed with the now available rare sample type that lane 9 is false negative for the drb1 *04:32 allele in the listed affected kit according to the labeling provided with the kit. product does not meet specification. however the primer mix in lane 9 is functioning as originally intended. the drb1*04:32 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through 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
Vascutek has recently identified that a labeling error has occurred during packaging for graft catalogue # 733020. it has been incorrectly labeled as graft # 732030. # 733020 relates to 30cm usable length and 20mm internal diameter while # 732030 relates to 20cm usable length and 30mm internal diameter.
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 urethral kit fibres may not illuminate along the entire length of the fibres which can result in inadequate visibility of the urethral structures during surgery.
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
Inaccurate results reported to the system when a sample is diluted and placed back into the system without assigning the sample a unique different sample id. as a result patient sample results may be reported with an incorrect result value resulting in inaccuracy imprecision or error comment reports together with the result.
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
Product was labeled incorrectly possibility that patient might not get oxygen.
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 varistor component to be missing in power supply. no potential for discrepant results or misdiagnosis. worst case scenario would a delay of results from loss of power.
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 received reports of leakage associated with the plastic hub of the spinal needles. the leakage condition is associated with an undersized luer taper in the spinal needle hub.
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
Panoscreen i ii and iii lot 24223 does not include an s positive donor cell.
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 had reports of these devices being occluded caused by inadequate lubrication applied to the slit in the upper seal of the valve boot.
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 negative bias of approx. 30% with level 1 was confirmed which may cause false positive results in samples at the cutoff value of 300 mg/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.
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 complaints of battery leakage on the infrared ear thermometer model 49531. ddc requested stop sale and remove from shelves.
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 fault can produce erroneous result flags on printed reports.
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
After a functional check of the brakes on the artis zeego system there is a possibility of any output system information being overlaid with different system information. the overlaid information requests users to contact the service department. the system remains operational but the rotary arm can only be moved at a reduced speed.
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 risk associated with operating the legendair for life-supporting applications relying on the internal battery only.
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
Affected device mail fail during use. potential exists for the tip of the inducer to fracture and become detached. no patient injuries to date.