Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Ge healthcare has recently become aware of a potential safety issue due to loss of gas monitoring associated with occlusion of specific d-fend/d-fend+ water traps used with compact airway modules e/m-c(ai)o(v)(x) and cardiocap/5 monitors. occlusion of specific lots of d-fend/d-fend+ water traps could occur immediately after replacement. this water trap occlusion could cause a loss of respiratory airway gas monitoring. when this issue is detected the connected monitoring device will issue an audio alarm and display “low gas sample flow”, “replace water trap” or “sampling line blocked” warning messages. unattended or prolonged warnings could lead to an adverse clinical situation if the co2 value would rapidly change in certain clinical conditions.
Acción
Customers are advised to collect and dispose of the affected water traps. GE Healthcare will replace all affected products. This action has been closed-out on 09/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Opti medical has identified that when so2 is below 80%, the bias on the thb is outside of their claims for measurement accuracy. the calculated parameters, hct and o2 (ct) are also significantly affected by the thb issue. the root cause is due to a shift in the wavelength of one of the lasers used to measure thb and so2. the shift occurred when opti switched suppliers of the laser.
Acción
End users are advised not to report tHb results from the affected device or use an alternative method to measure tHb when SO2 is below 80%. The Hct and O2(ct) calculated parameters should also not be reported when SO2 is below 80%. Users are strongly recommend to review patient tHb results when SO2 results were below 80% to determine if any adverse events have occurred. A software update is being developed to correct the issue. This action has been closed-out on 09/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens has detected a situation with bcs / bcs xp analysers regarding factor ix assay determinations for haemophilia b patients. internal investigations showed discrepancies for siemens bcs / bcs xp within dilution studies. siemens has confirmed that samples at the lower measurement range were found elevated on the bcs/bcs xp system. patient results in the lower measuring range may be misclassified within a higher factor ix level. patients that have been evaluated for hereditary factor ix deficiency disease for the first time may have to be re-evaluated.A falsely elevated factor ix level may lead to a delay in diagnosis of a bleeding disorder related to factor ix deficiency. this may lead to additional diagnostic testing and delayed prophylactic therapy.
Acción
Siemens has provided a workaround for users along with a technical support contact number, whilst a permanent fix is being developed. Customers are advised to follow their laboratory protocol regarding the need for review of previously reported patient results.
This action has been closed-out on 01/03/2018.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens has identified that some systems may have been manufactured with a defective reagent carousel temperature sensor pcb or a defective pcb assembly.The affected temperature sensor boards may cause icing on the reagent carousel casting. if there is icing within the reagent carousel, there is a potential for the reagent carousel to encounter a mechanical jam which will stop the system from processing samples and will generate errors.Siemens has determined that the reagent contents do not freeze when the incorrectly assembled pcb assembly is installed in the reagent carousel assembly. testing shows that the reagent liquid temperature may fall below 4 °c but not to the point when freezing or slush was observed. the reagents are not compromised; therefore, assay performance is not affected.There is not likely to be any risk to health. the system will stop processing samples if a mechanical jam occurs.
Acción
Siemens will inspect all systems for the defect on the next service visit. In the interim users are requested to contact Siemens Technical Support should an Error [465] or [302] occur. This action has been closed-out on 03/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Heartware is providing further information to users regarding:1. worn alignment guides, 2. internal "double disconnect alarm" battery, 3. power management software upgrade, 4. driveline outer sheath discoloration & cracking, and 5. snagging or pulling of the driveline.
Acción
HeartWare is reiterating warnings and precautions stated in the Instructions for Use and Operators Manual to ensure the safe use of the devices. HeartWare is also notifying health care professionals of an additional warning regarding discolouration and cracking of the drive line due to exposure to UV light.
Further information can be found ont he TAG website at https://www.tga.gov.au/alert/heartware-ventricular-assist-system
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Coopersurgical has identified that there may be product with customers that have been in inventory for more than five years. some users of the transwarmer infant transport mattress may have removed individual units from the original packaging and have been using the device past the labelled and recommended expiration date.Serious burns have been reported in the past and could occur if the products are not stored under the labelled conditions or used beyond the recommended shelf life. coopersurgical has received three complaints from the field indicating that the product may activate at higher than labelled temperatures.
Acción
CooperSurgical is requesting all users to review their inventory and discard or return any product that does not display a product LOT code or expiration date on each individual unit. The brands affected include CooperSurgical and NovaPlus labelled TransWarmer Infant Transport Mattress. The LOT code and expiration date can be located on the top left corner of the individual pouches.
All new units will have the lot and expiry date on the individual unit packaging. This action has been closed-out on 17/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Johnson & johnson is initiating a recall for product correction for the depuy synthes tfn-advanced proximal femoral nailing system (tfna). the tfna system is intended for treatment of proximal femoral fractures.There is the potential that the tfna nails received before march 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail. this problem was due to human error during assembly of the device with the manufacturer and no design changes are required.Therefore locking mechanism could:· prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or· cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.The above may lead to delays in surgery with the potential for complications associated with prolonged anaesthesia.
Acción
A workaround is being provided for users via the customer letter. This action has been closed-out on 08/08/2016.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
There is the potential for a sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray and does not directly affect the sterility of the device componentsthis potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. the breach in the pouch barrier may not be detectable by visual inspection of the product. medtronic has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.
Acción
Customers are asked to review their inventory, quarantine product, complete the customer confirmation certificate and return all unused product to Medtronic. This action ha been closed-out on 10/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
An issue related to out-of-range-low (oorl) flucytosine (fct) qc results for candida krusei atcc 6258, the package insert qc strain, has been identified in association with the vitek 2 ast-ys06 and ast-ys07 test kits.Internal investigation at the manufacturing site has observed the oorl fct qc results for candida krusei atcc 6258. internal testing of fct with additional isolates shows a trend to call one to two doubling dilutions low. candida krusei are intrinsically resistant to fct and are therefore forced "resistant" in vitek 2 software (as of version 7.01); the vitek® 2 7.01 fct forcing rule does not apply to other candida species. user reports have been limited to the atcc 6258 qc strain; however, impact to patient results for candida krusei and other yeast cannot be ruled out.
Acción
For the referenced test kits (VITEK 2 AST-YS06 or AST-YS07), laboratories are advised to not report Flucytosine (FCT) results for any organism until the new formulation (fct02n) is released.
This issue will be resolved with the release of a new Flucytosine (fct02n) formulation. The estimated timeframe for introduction of cards with the new Flucytosine formulation is six months. This action has been closed out on 09/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Investigations by the manufacturer remel europe, part of thermo fisher scientific, have confirmed that this batch of group b reagent may produce weak or slow reactions. continued use of this batch may result in a failure to identify beta-haemolytic streptococci group b isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.
Acción
Laboratories are requested to cease using and destroy the kits containing the affected reagent. This action has been closed-out on 08/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Dickson & dickson healthcare have received a corrective action notice from the manufacturer of this bed to replace incorrect product labelling. prius beds manufactured in may 2015 and july 2015 have the incorrect manufacturer details stated on the label. after consultation with tga, dickson & dickson healthcare ltd is performing a recall for product correction to replace affected labels with the correct information.The labels are to be replaced on all beds in order to comply with the essential principles.
Acción
Dickson & Dickson Healthcare is arranging replacement of the labels on all affected beds which will display the correct manufacturers details. This action has been closed-out on 03/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The reason for the recall is due to a possible breach of the package’s sterile barrier, therefore compromising the sterility of the product. the breach may not be easily seen. it is important to note that there are no concerns regarding the diego elite product performance. however, as a result there has been a temporary disruption in the supply of diego elite tube sets.
Acción
End users are requested to cease use of any affected product and quarantine it until it is shipped back to Olympus Australia Pty Ltd. This action has been closed-out on 08/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Invacare has learned that the psi (pressure sensitive interrupter) design for the compressor motor start/run capacitor (dianz brand)could lead to rupture. that capacitor in the oxygen concentrator has an internal pressure relief component (the psi) which may not operate as intended permitting the capacitor to rupture in certain circumstances. if the psi does not function to relieve the heat and pressure due to a short circuit within the capacitor, then the pressure can cause a rupture in the seam between the housing and the end plate. if the rupture occurs, the oil may be expelled from the capacitor which may result in a fire hazard. these capacitors were utilised in production from march 2010 to august 2012 at one of our manufacturing sites.
Acción
Invacare is providing instruction on how to identify if an affected capacitor is present in the oxygenator. If present end users are requested to contact their distributor to arrange for a technician to replace the capacitor.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Investigations have confirmed that this batch of gram crystal violet may be contaminated with an environmental gram-negative bacillus. continued use of this batch may result in an appearance that those cultures being stained include a gram-negative rod, or that otherwise sterile samples may contain this organism.
Acción
Laboratories are requested to cease use and discard the affected lot of Gram Crystal Violet. This action has been closed-out on 03/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
An internal investigation showed that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this malfunction can occur with defibrillation electrodes that are older than 2 years. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. the precise cause for this is still under investigation. the electrodes are being in used in connection with the defibrillators corpuls 08/16, corpuls1 and corpuls3. other defibrillation electrodes manufactured for the corpuls defibrillators are not affected by the problem.
Acción
Device Technologies Australia (DTA) is requesting their customers to isolate the affected electrodes. DTA is contacting the customers with a Good Return Authorisation (GRA) number and arrange collection. Replacement paediatric leads are available and will be provided as soon as possible. In the interim, if no paediatric defibrillation electrodes are available, DTS advises that standard adult electrodes may be used for defibrillation of patients <25kg. This action has been closed-out on 08/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The current instructions for use reports the interference from n-acetylcysteine (nac) evaluated on a commercially available analyser. using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/l n-acetylcysteine (nac) in a 104 ìg/ml (688 ìmol/l) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of nac to a serum pool.Based on testing performed by sekisui diagnostics on an architect csystems instrument, the concentration of nac at which acceptable acetaminophen results are obtained is 200 mg/l nac in values from a 109 ìg/ml acetaminophen sample, tested two hours after the addition of nac to a serum pool.The package insert is being updated accordingly based on these results.
Acción
Laboratories are advised that treatment with N-acetylcysteine (NAC) could interfere with the assay to a greater extent than previously indicated resulting in negative bias. The Instructions for Use have been updated with this warning. Laboratories are advised to follow their protocols regarding the need for review of previously reported results. This action has been closed-out on 18/04/2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Resmed received an incident report involving circuit disconnection of a patient in a hospital where the device alarms did not operate because all alarms had been disengaged by the physician and the patient required medical intervention.
Acción
ResMed advises that, as long as the disconnection alarm is not disabled for high-dependency patients who are using the device continuously, as directed in the Instructions for Use, the above safety concern will not occur. Alarm configurations can only be changed by health professionals and cannot be modified by the patient in the home. ResMed intends to release and install an updated version of Astral software, in three months’ time, in which the circuit disconnection alarm for all ventilation modes for dependent patients cannot be deactivated. For more details, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators. This action has been closed-out on 05/09/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
When epiq 5 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may occur which results in the incorrect calculation of the patient’s body surface area (bsa). when using both height and weight to calculate the bsa which is the usual practice for patients above the age of 2 years an error factor of about 10 may be applied which would be readily identified by the user.Alternatively, when using weight only the bsa may be out by a factor of about 1.7 which is much harder to detect as a cardiac index calculated using that value may not be as obvious to the user. however it is highly unlikely that this type of calculation would be used for patients older than 2 years of age. therefore, the risk of this error occurring is greatest when the bsa is calculated using weight only in patients under 2 years of age.
Acción
Philips has corrected this issue in software version 1.3.3. which will be provided to users free of charge.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
When epiq 5 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may occur which results in the incorrect calculation of the patient’s body surface area (bsa). when using both height and weight to calculate the bsa, which is the usual practice for patients above the age of 2 years, the result may be out by a factor of about 10, which is an error that would be readily identified by the user.Using patient’s weight only to calculate the bsa would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.
Acción
Philips has corrected this issue in software version 1.3.3. which will be provided to users free of charge. This action has been closed-out on 05/09/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This recall has been initiated from the advice of medline’s supplier medtronic, involving lot numbers 508xxxx and below. these light gloves may contain splits and pin holes. if a clinician touches the handle unaware that the light glove is split and or contains pin holes, microorganisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection.
Acción
Medline is advising end users to remove the Light Glove from the procedure pack and discard at the point of surgery. This action has been closed-out on 16/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Medtronic has identified the potential for an issue with a specific set of lot numbers of medtronic neurovascular products where the ptfe (polytetrafluoroethylene) coating could de-laminate and separate from the delivery wire. de-lamination and detachment of the ptfe coating material may lead to ptfe coating in the blood stream. ptfe in the blood stream, based on its specific size and quantity could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial oedema, peripheral oedema, incomplete treatment, infection, local inflammatory response, systemic inflammatory response, ischemic stroke, lysis/necrosis, neurological deficit, organ impairment, shock, space occupying lesion, thrombosis, and haemorrhage.Through september 27 2016, medtronic has received a total of five (5) reports for the products that are potentially affected by this issue however; no reports of serious injuries or patient death have been reported.
Acción
Customers are advised to quarantine and remove all unused affected products in their inventory. Medtronic will be issuing a credit for the returned, unused and unexpired device(s). If replacement product is needed, Medtronic representative can assist customers with identifying suitable replacement products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with your standard patient management protocol.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
New interference claims for trinder tests have been verified by roche internal studies.Trinder tests measured in samples which contain nac, napqi, and metamizole may show inaccurate results. the severity depends on the clinical situation and the therapeutic state of the patient. it is good clinical practice not to take blood from a patient immediately after administering medication, except in the case of therapeutic drug monitoring. nevertheless under certain, rare circumstances there is insufficient time between the administration of a drug and blood sampling, which may lead to accuracy issues with the trinder tests.Roche has identified:1. falsely low crea plus results for patients with a toxic level of acetaminophen under treatment with n-acetylcysteine (nac). 2. falsely low results of crea plus after intravenous injection of metamizole.The crea plus results were below the measuring range, while plausible results were obtained with the crea jaffé method.
Acción
Laboratories are advised to be aware that the recovery of Trinder tests may be falsely low when the blood sample is taken while levels of NAC, NAPQI, and Metamizole are still present.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Under certain circumstances the following user actions may cause the system to freeze. ·when images were transferred from the left monitor to the right monitor (function a to b) during image acquisition (i.E. radiation on) or shortly before starting image acquisition·when acquisition of image was started while storing of scenes initiated by pressing the store button was still in progress·when scene replay was initiated either automatically or by pressing the “play” button (especially when pressing the “play” button more than once) while the storing of those scenes was still in progress·when image acquisition was initiated again before automatic replay of the last scene started·when finalized cd/dvds were used to store additional data·when radiation summary reports with more than 190 entries were being exported·when system restart was initiated when the error message “system blocked. turn system off/on” (error codes 215/80 and/or 208/80) was displayed.
Acción
Siemens has provided a workaround whilst a system modification is being developed which is expected for July 2015. This action has been closed-out on 11/08/2016.