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
The inhibin a certificate of analysis has the incorrect unit of measure listed as iu/ml. the correct unit of measure is pg/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
Sysmex has identified a software bug with cs-2000i and cs-2100i software version 60 (v00-60) and all previous software versions. in the software certain error flags highlighted for review are automatically validated and sent to the host computer. these error flags are not being held back for manual review as expected.
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
Increased frequency of control values recovering out of the defined rangeinvalidating the assay. this is an expansion of recall for the liaison control mumps igg lot #s 164007x & 164007x/1.
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 vumax ophthalmic ultrasound system may under certain circumstances return measurement values on the order of 1/2 or 2x the actual value. root cause is a software conflict within software version v2.0.06e.
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 aquilion one system due to the problem of software and other a part of the image-related information may be abnormal or an error may occur at the time of scan setup when sure exposure 3d is 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
When analyzing multiple listmode files it is possible that the percentage results displayed within the plots will be incorrect when using cytomics rxp software version 1.0.
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
Tip of salute may wear and affect the constructs. proper cleaning and maintenance may not be followed. maximum number of constructs may be exceeded.
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 improved prozone check limit ensures correct flagging of samples exceeding a concentration of 1000mg/l.
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 assembly process of one lot of condensers rotary file tips were attached to condenser handles and packaged as condensers.
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
Iris international has become aware of loose or missing analyte pads being found in several locations (strip vial stip provider module stip conveyor system or waste container) that are undetectable by the ichem velocity system. if affected strips are used to assay patient samples the issue has the potential to cause erroneous ph results and false negative results for the following tests: nitrite glucose blood bilirubin urobilinogen protein leukocyte esterase ketones and ascorbic acid.
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
Under certain circumstances archived data may be lost from the archive of xcelera r1.1.
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 cobas b221 reference electrode has a lifetime of 52 weeks but is not documented in the analyzer manual. customers had not been sufficiently informed regarding this limitation. they may find themselves using aged electrodes leading to leakage. ultimately this may cause a ph and a na+ offset which may result by incorrect diagnosis and treament.
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
Updating the instructions for use for the pressure display box and disposible sets included in the sorin group usa custom perfusion tubing pack for the revolution centrfugal blood pump. the update will reflect the current performance of the display box.
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
Zoll e series defibillators with software versions 3.00 and higher may transmit or print incorrect patient records.
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 anomaly was detected in the bact/alert 3d b.40.Xx firmware affecting bact/alert 3d signature and seleclink configuration. in specific circumstances the optimal growth detection algorithm may not be assigned to a bottle under test.
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 patient progesterone samples processed from primary sample tubes may produce falsely low results. effect not observed when samples are poured into sample cups and then analyzed. dk.
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
Kits may contain b+a- control agent incorrectly labelled as a+b- control reagent.Although label is incorrect bottle contains correct influenza b positive control antigen and correct lot number exp.Date.
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
Risk of disconnection of portable patient lift from attachment handle if used with the original smaller carabiner.
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
Vials have been packed in cartons labeled as tdm performance verifier i and tdm performance verifier ii lot number and expiration date.
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
Pelton & crane became aware via 3 internal failures in production that the link arm assembly that connects some rear mounted options (cuspidors assistants instrumentation and hygiene systems) to the spirit 3000 dental chair may potentially break and fall off the dental chair.
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 inc. (bec) has identified the following issue with the product listed in section a: the dxh 800 systems with software revision 2.0.0.1 transmits a fixed date/time field (december 30 1899) and an empty serial number field in the ret# string for 1)retic-x and 2) patient controls analyzed using "retic" as the test type.
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
Bard has identified arctic sun 5000 temperature management systems with specific serial numbers that may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system clock and static random access memory (sram). this premature coin cell battery drainage could render your device unresponsive upon system startup.
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
Arrow is recalling certain lots of the products referenced above due to reports clinicians have had difficulty maintaining a secure connection between the male luer of the tuohy borst adapter of the vascular positioning system stylet to the hub of the catheter. when the connection is not secure there is a possibility the connection will leak saline. this is most often discovered during initial flushing prior to insertion in which case a delay in treatment can occur while the health care provider locates a replacement device. in the unlikely event that the issue is discovered while the device is in use it could result in an inability to obtain a signal on the vps console. this would in turn necessitate removal and replacement of the catheter or an x-ray to confirm proper catheter placement.