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
Philips healthcare received a report that during a manual collimator exchange procedure, when the operator was attempting to slide the collimator cassette from the collimator storage cabinet onto the collimator exchange carriage, the cassette did not align with the carriage top guide rollers and mechanical lock. the collimator and collimator cassette fell off the carriage resulting in the operator receiving a minor injury. this could result in serious injury to a person if it comes in direct contact with the operator. automatic collimator exchange system is not affected.
Acción
Philips Healthcare is instructing their customer not to proceed with collimator exchange procedure, if a misalignment on the top and/or bottom of the guide rail between the cabinet and carriage can be visually detected Philips Healthcare service technician will fix the issue prior to the continued use of the system.
UPDATE: Philips is advising their customer that they must ensure collimator alignment is inspected via regularly scheduled Preventive Maintenance at 3 month intervals. An updated procedure for inspecting collimator alignment has been provided. This action has 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
Siemens healthcare diagnostics has confirmed that the immulite 2000/immulite 2000 xpi italian cypress allergen lot 206 does not meet the shelf-life stability as indicated on the label. this may lead to single class change decrease (standard classification) in patient results across the current shelf-life of this allergen lot. patient dose values may decrease before the stated expiry date listed on the allergen vial.It is expected that lot 208 will also not meet its current shelf life stability and must be discarded after june 30, 2015.
Acción
Siemens is requesting laboratories to discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen from lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Laboratories are requested to discontinue use and discard lot 208 after June 30, 2015.
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
Images successfully transmitted to intelepacs may not be available for reading in all studies, and the reader could be unaware of missing images.. this failure can be detected if the client has image count verification protocols. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy.This issue can arises in two scenarios:1. for the three clients that employ ingest servers to provide temporary store-and-forward capabilities in their architecture, in some conditions, these servers fail to forward all received images to the permanent storage servers and no record of these images persist in the main archive. 2. for the remaining client architectures that do not employ temporary ingest servers, there is still a very low probability of failure for the device to properly replicate and register images when transferring them to another server.
Acción
For the three clients using a configuration with ingest servers as temporary storage, an immediate update process was undertaken via the Client Specific Release process (completed as of 2015-04-23) to avoid the possibility of data loss. For the remaining clients, the normal Full Release Update (FRU) will be expedited. This action has been closed-out on 5/08/2016.
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
A serious safety concern has been identified during the preliminary primary data analysis from the serve-hf clinical trial. this trial investigated the effect of adaptive servo-ventilation (asv) therapy on the hospitalisation and mortality rate of patients with symptomatic, chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef = 45%) and moderate to severe predominant central sleep apnea. the identified safety concern is a significant increase in the risk of cardiovascular death in patients with symptomatic, chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef = 45%) being treated with adaptive servo-ventilation.
Acción
Resmed is advising physicians managing patients who are having symptomatic chronic heart failure with reduced ejection fraction and predominant central sleep apnea who are using ResMed ASV devices that they should contact their patients to discuss discontinuation of treatment. For more details, please see https://www.tga.gov.au/alert/resmed-devices-use-adaptive-servo-ventilation-therapy. 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
Smith & nephew internal investigation found the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. to date there have been no complaints or adverse effects associated with this issue.This could potentially lead to a post-operative infection.To date there have been no complaints or adverse effects associated with this issue.
Acción
Smith & Nephew is advising their customers to inspect the inventory and quarantine the affected devices immediately. A Smith & Nephew customer service representative will contact the customer to arrange collection of any affected products and advise on substitute devices available. This action has been closed-out on 11/08/2016.
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
When epiq 7 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient’s body surface area (bsa). using patient’s weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, 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.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. This action has been closed-out on 15/08/2016.
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
When epiq 7 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result 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 too high by a factor of about 10, 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. Phillips has provided work around instructions until the software update can be provided. This action has been closed-out on 5/09/2016.
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 affiniti 70 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result 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 too high by a factor of about 10, 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 1.0.3. which will be provided to users free of charge. Philips has provided work around for end users to use until the software update is provided. This action has been closed-out on 04/05/2017.
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
When affiniti 70 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient’s body surface area (bsa). using patient’s weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, 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.If a healthcare provider makes a clinical decision on the basis of a cardiac index calculated using an incorrect bsa without considering other indicators of cardiac function, misdiagnosis and/or delayed or incorrect therapy may result.
Acción
Philips has corrected this issue in software version 1.0.3. which will be provided to users free of charge. Philips has provided work around instructions for end users to use until the software update is provided. 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
When affiniti 50 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result 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 too high by a factor of about 10, 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 1.0.3. which will be provided to users free of charge. Philips has provided work around instructions until the software is implemented. 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
Covidien is conducting this recall following reports from customers where patients who recently switched from the current shiley neonatal and pediatric products to these affected products as listed above, experienced discomfort immediately after the switch in a limited number of situations. in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch. in all reported cases, patients were administered immediate medical attention. serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall. there have been 12 reports of serious injuries. no deaths have been reported.
Acción
Covidien is requesting hospitals to discontinue use and quarantine all affected devices. Covidien will organise for the recovery of the affected devices.
If one of the recalled Shiley tracheostomy tubes is currently in use in a patient, and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, Covidien recommends that the patient’s physician evaluate the continued use.
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 analyzers will potentially not indicate the error codes below: error code: d50 glucose sensor errorproblem: the system detects an open connection in the glucose biosensorerror code: d51 lactate sensor errorproblem: the system detects an open connection in the lactate biosensor.If the error codes were functioning properly, glucose or lactate results would be suppressed in the presence of their respective code. while a disconnected glucose sensor could result in falsely elevated or depressed glucose values, the risk is limited to a falsely elevated glucose result that could potentially lead to a missed or delayed diagnosis of hypoglycemia requiring intervention. while a disconnected lactate sensor could result in falsely elevated or depressed lactate values, the primary risk is limited to a falsely depressed result that could potentially lead to a missed/delayed diagnosisand/or an inaccurate evaluation of the severity of sepsis, ischaemic and hypoxic conditions.
Acción
A look-back of previous results is at the discretion of the laboratory. A new software version for the RAPIDLab 1260 and RAPIDLab 1265 analyzers is being developed to address this issue, and will be provided by Siemens as soon as it is available. In the interim, users are advised to ensure that the Glucose and Lactate sensor contacts are aligned and completely seated with the contacts on the analyzer and analyze a minimum of 2 levels of quality control material after installing the sensors, as indicated in the RAPIDLab 1200 Operator’s Guide.
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
Perkinelmer have become aware through a customer complaint that the content of the second of the two #023 barcode id labels provided on each page of the barcode id label binder are incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. in the event measurement protocols have been programmed for both id #023 and #024, and the wizard2 gamma counter scans the affected barcode label, the protocol associated with barcode id #024 is executed. if the error is undetected, the wizard2 gamma counter may produce erroneous results.The impact on health is dependent on the clinical application in which the wizard2 gamma counter is being used.The issue will lead to a delay in reporting results due to the delay to resolve the issue and retest the samples or test new samples. dependent on individual patient clinical status an incorrect result may impact disease progression or renal function.
Acción
Users are advised to ensure that they remove the barcode labels ID #023 from all barcode label binders in their possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided to affected customers. 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 incorrect label was applied to the product that is the subject of this action. certain lots of the chisel blades that were shipped to your facility may be labeled as “not for human use; for veterinary use only”.
Acción
The incorrect label was applied to the product that is the subject of this action. Certain lots of the Chisel Blades that were supplied may be labelled as “NOT FOR HUMAN USE; FOR VETERINARY USE ONLY” This action has been closed-out on 03/03/2016.
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
Sequential reaming of the patient's femur was being carried out during a total hip replacement(thr) procedure. following the use of the 8mm reamer, the 10mm reamer was introduced. during reaming the bottom of the reamer broke off while lodged in the patients femur, approximately 40mm below the resection level. a distal window was cut into the femur, and the broken section of the reamer removed. under torque the reamer broke at a weld joint. the joint was insufficiently strong.This action is undertaken prior to notifying the tga.
Acción
Global Orthopaedics Technology has retrieved, quarantined and returnign all affected reamers to the manufacturer. The manufacturer, Omni Life Sciences, has obsoleted the design used for the affected reamers.
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
During packaging verification testing, a breach in the sterile barrier was observed in some of the units tested. additional testing identified microscopic aluminium metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches in some of the units tested. it was determined that these particles were introduced during the manufacturing process and were sterilised within the tyvek pouch with the product. the potential hazards of this product issue include patient exposure to infectious material, potentially leading to patient infection, and patient exposure to sterile foreign material potentially leading to foreign body inflammation.
Acción
Customers are asked to check any PenAdapt items in their possession and quarantine any affected units immediately. A Stryker Representative will contact customers to coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued to the customer account. Stryker is also requesting the customers to review the patient records for issues that may have been associated with the use of the affected device, such as infection and/or inflammation.
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
Recapped tubes can lean in their storage holes, causing them to touch neighbouring tubes and interfere with the movement of the robot gripper. the gripper does not have enough space to properly place the tubes in the storage racks due to leaning tubes in the racks. there is a potential for the caps to fall off of or be knocked from sample tubes placed in the storage racks of entry/exit modules. there is also the possibility for the gripper to grab a tube at the wrong height and drop the tube in the entry/exit modules. these situations may result in splashing of bio-hazardous fluid, and sample cross-contamination may occur if there is an uncapped tube in the rack.
Acción
The rack profile configuration has been modified in a way that tubes are loaded to only every second position. Because existing rack is used, this does not require new software release for TCA. This modified rack profile configuration will prevent tubes to lean too close to the next one while loading it and thus preventing possible collision.
Thermo Fisher is recommending their customers to install the modified rack profile configuration. Installation of the modified rack profile can be done by authorised service engineer.
Thermo Fisher will release a new version of storage cap which has bevelled upper part to ease gripper and tube movements. Release is expected in a few months.
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 system is designed to emit an acoustic signal (beep) upon termination of an exposure. however, if the system has been powered on for more than 12 hours, the system will no longer emit this signal.
Acción
Philips recommends that the system is rebooted at least every 11 hours until the software is upgraded. A Philips service engineer will contact the customers to implement the software upgrade to release 02.3400.015. This action has been closed-out on 17/08/2016.
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 healthcare diagnostics has observed a system-to-system bias between the tni-ultra assay on the following systems:- advia centaur cp and - advia centaur- advia centaur xp- advia centaur xpt the advia centaur cp is generating lower results than the advia centaur/advia centaurxp/advia centaur xpt system. siemens is actively pursuing the cause of this issue.
Acción
Siemens is providing end users with information to assist with the interpretation and release of troponin results. Siemens internal investigation has confirmed the clinical utility of the assay at the 99th percentile for healthy individuals (0.02 - 0.06 ng/mL (µg/L)) is not impacted by this issue.
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
Recent revisions of the device’s instructions for use (ifu) (part number 989803162691, rev. f- rev. h) inaccurately indicates that one of the temperature probe’s application sites is “endotracheal”. the application site should be listed as“esophageal”. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.. should the flextemp reusable temperature sensor be inserted into the patient’s trachea, patient infection or airway blockage may occur if any part of the flextemp temperature sensor or flextemp system jacket is left in the patient upon removal, or if the flextemp system jacket is damaged and sterilization compromised.
Acción
Philips is providing the customers with an errata sheet to the Expression IFU, which removes endotracheal as an application site. Philips is working on a solution to this issue and once a solution is available, Philips will provide the customers with another communication outlining the plans for implementing the solution. This action has been closed-out on 24/08/2016.
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 affected berichrom protein c product lots may lead to a failure of calibration on the above sysmex instruments, where the calibration curve is indicated as invalid due to the 0% point of the calibration.
Acción
Siemens advises that in case the Berichrom Protein C calibration curve on your system is indicated as being invalid due to the 0% calibration point the mentioned calibration point has to be set manually to “0” dOD.
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
Internal testing by ortho-clinical diagnostics, inc. (ocd) has determined the need for revisions to the low end of the measuring range for the assay. this revision affects the limit of blank (lob), limit of detection (lod), limit of quantification (loq) and reportable measuring range.
Acción
Ortho-Clinical Diagnostics, Inc. (OCD) is providing the updated Instructions For Use (IFU) and instructing the customers to implement the revisions on the VITROS System as below:
- For VITROS ECi/ECiQ Systems: Scan the Magnetic Lot Card for Lot 1250 & above.
- For VITROS 3600, 5600 Systems: Install ADD DRV 5815 & above.
- Update the laboratory procedures and Laboratory Information System, as required.
The revision to the low end of the Measuring (Reportable) Range may affect the Laboratory Information System. Users are advised to consult with their Information Technology representative to determine the impact at their facility. IFU documents are also available on the Ortho-Clinical Diagnostics, Inc. (OCD) website.
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
Issue 1: samples may stop processing without notification on the dimension vista 500 or dimension vista 1500. this issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable. issue 2:complaints were received on the dimension vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. it has been determined that under a rare set of conditions, a timing issue may cause a reagent server to temporarily lose synchronisation during the automatic removal of reagent cartridges from reagent server 2 to waste a container. in the extremely unlikely circumstance that this issue occurs, a flag will be generated for the majority of assays. however, there is the potential to produce unflagged erroneous but believable results for some assays.
Acción
Users are provided with temporary workarounds in the customer letter. Siemens will be providing corrections for the issues in a future Vista software version. Review of previously generated results due to this issue is at the discretion of laboratory. This action has been closed-out on 26/08/2016.