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
It has been determined that a limited number of avoxmeter 1000e cuvettes have exceeded internal control limits for gap measurement. the gap measurement is incorporated into the pathlength value, which in turn is entered into the settings of avoximeter instruments when a new lot of cuvettes are used to run a test. the pathlength values add an additional degree of accuracy in the total haemoglobin (thb) reported value and those calculations where thb is used as a variable. the pathlength values do not affect %02hb, %cohb or %methb results.The affected avoximeter cuvettes may have a slight upward shift in pathlength that can result in a clinically insignificant corresponding downward shift in thb. in a worst case, this shift may cause the reporting of a thb result approximately 5% lower than the actual thb value (e.G. an actual value of 10 g/dl is reported as 9.5 g/dl). the shift presents a low risk to health in the intended clinical uses associated with the avoximeter system.
Acción
Zoll Medical is advising users of the possibility of a downward shift in tHb values with the affected lots.
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
Stryker has become aware during an internal review that some items of the star sterile instrument kit have been unintentionally shipped to australia without being ce marked. non-sterile instrument alternatives are available for the australian market. based on design review by stryker and the availability of the necessary ifu information, no hazards are to be expected.
Acción
Customers are advised to inspect the inventory and quarantine any affected stock immediately. A Stryker representative will coordinate the return of any affected product. This action has been closed-out on 11/05/2017.
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
Cynosure has identified an error in the expiration date on the label of the minor surgery bipolar cable pouch. the expiration date on the individual pouches that are provided in the 5 pack boxes does not match the expiration date on the box. the expiration date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. if the cable is used after that date, sterility may be compromised.
Acción
Customers are advised to return any affected cables that they hold. Cynosure will be replacing affected cables upon receipt of the returned cables. This action has been closed-out on 12/05/2017.
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
A typographical error has been identified in certain quantum blue calprotectin assay kits. the printed expiration date on the labelling of the kits is incorrect. the correct expiry date is 2016-dec-31. there is no risk to health if the assay kits are used by this date.
Acción
Taylor Biomedical has advised customers to check if they have affected stock. Customers will be requested to include in the affected stock, an advisory notice with details of the correct expiry date.
This action has been closed-out on 28/11/2016.
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
Cepheid has received reports that some customers have experienced cartridge performance issues that manifest as abnormal pcr amplification curve patterns, which can yield invalid results (the most common outcome), or much less commonly, inaccurate quantification of hiv-1 rna when using this test and its intended use specimen types.
Acción
Cepheid is advising users to stop using and dispose of any remaining product from the affected lot (Lot Number 1000034821). Replacement product will be provided. The results of previous tests performed with this lot of product should be discussed with the laboratory medical director to determine whether a look-back is required. If there are any concerns about the accuracy of the results contact Cepheid Technical Support who will analyse the GeneXpert data files (gxx files). This action has been closed-out on 10/05/2017.
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
Roche is updating the cleaning procedure for rack trays that are used with various cobas, modular analytics and urisys instruments as a result of reports of injury caused by sharp edges on the rack trays during cleaning. cuts may occur when fingers come in contact with rack tray edges, especially if a quick wiping movement is made along the edges of the rack tray. the updated cleaning procedure contains instructions for safe handling of the parts to avoid the risk of injury.
Acción
Roche is providing users with updated cleaning instructions for the rack trays. This information will be incorporated into future versions of the respective instrument Operator Manuals. 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
It has been identified that when running monaco v 5.10 or v 5.20 and creating 3d plans using either mu or dose weighting modes, if the user changes the physician's intent rx dose and the number of fractions, and then modifies the wedge angle, the monitor unit (mu) value is scaled incorrectly. the scaling of the mu is in direct proportion to the fractional change.If the mus are not correct, the patient will be incorrectly treated. there could be a critical overdose or underdose proportional to the fractional rescale. however, prior to treatment, independent dose calculation checks and secondary mu checks should always be done. both should be standards of practice in radiation therapy clinics and will detect the problem.
Acción
Elekta is advising users that the issue is resolved with Monaco release 5.11.00 which is available now and with patches for versions 5.10 and 5.20. Elekta is also advising users that dose calculation checks and secondary MU checks should detect the problem, and that the problem can be avoided by forcing a Monaco recalculation (change dose calculation grid spacing and change back) when any wedge angle change is made.
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
It has been reported that an ez-strip product from the stated lot may contain debris that could result in the device failing to perform its intended purpose. this fault, if not identified by the customer could result in the loss of oocytes.
Acción
Key IVF Supplies are advising customers to cease use of the affected lot and immediately quarantine all remaining packs. Key IVF will arrange for the collection of the quarantined packs and will replace affected stock. This action has been closed-out on 02/03/2017.
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
Invacare are updating the instructions for use with respect to correct assembly of the d-clip that connects the actuator to the birdie lifter’s arm. as a result of some reports overseas where the actuator’s d-clip becomes damaged and the lifter arm falls down, invacare have become aware that if the d-clip is always placed backwards and pointing down towards the actuator (incorrect assembly), it can start to become damaged after a number of cycles. if the d-clip becomes damaged to the extent that the lifter arm falls down then there is potential for a serious patient injury to occur. when the clip is in the wrong position the bending (damage) of d-clip only happens if it is touching the actuator backwards and at its maximum height. the clip will also bend severely when over 140kg is used with the device. the complete clevis pin (quick release pin) doesn’t detach immediately from the actuator when the d-clip becomes damaged - the pin stays in the arm’s plates that hold the actuator.
Acción
Invacare is advising customers that the following should be checked on each Birdie Lifter.
1. The actual state of the D-clip - does it appear bent or broken? If the D-clip is damaged or broken, Invacare should be contacted and they will provide replacement stock.
2. The actual position of the D-clip in the lifter. If it is in the correct position, there is no need to change it. If it is assembled in the wrong position, the D-clip should be removed and reassembled according to the directions that are being provided.
Revised instructions for use are avaliable.
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
The zero-gravity radiation protection system achieves its nearly weightless support of the body shield by employing a steel cable attached to a balancer. two reports from users of the system suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. while no injuries or deaths occurred in either failure, the zero-gravity body shield weighs 25 kg, and in the event of a cable failure, the body shield will fall immediately. a fall of this nature places the user, associated staff and the patient at risk for a potentially serious injury.
Acción
Biotronik will be contacting users and arranging for the replacement of the cable. In addition, the instructions for use and protocols will be updated to include a step to allow the cable to unwind after each use. In the interim, users should inspect the cable for signs of wear or rotational tension that may have created a bend or buckle in the cable. Also, users should review their routine use of the Zero-Gravity Radiation Protection System to determine if the body shield undergoes repeated rotation without allowing the cable to relax back to its normal condition. If the cable has been consistently rotated in one direction without being allowed to relax back to its normal condition or if there is any doubt about excessive rotation in one direction, it is recommended that use is discontinued until the cable is replaced. If facilities continue to use the System until the cable is replaced, they should make sure that they are allowing the unit to go back to its relaxed state. This action has been closed-out on 25/05/2017.
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
An additional warning is to be included in the operator's manual with the advice that the arctic sun temperature management system is not to be used in the operating room environment. this is to address concerns regarding the potential for non-tuberculous mycobacterium (ntm) bacterial transmission to a patient based on use of the device in operating rooms and sterile fields under existing labelling. the probability of harm to a patient is considered remote.
Acción
Bard is providing customers with operator's manual addendum which contains the additional warning that the Arctic Sun Temperature Management System is not intended for use in the operating room environment.
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
Customers have reported that on rare occasion (complaint rate less than 2/100,000 or 0.0017%), the devon light glove may split upon application to the devon light handle adapter. a subset of these splits reportedly resulted from a difficult application of the glove to the handle adapter. a split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. there have been no reports of serious injury associated with these rarely occurring splits.
Acción
Medtronic is adding the statement "After application, inspect the Light Glove for barrier integrity" to the Devon Light Glove Instructions for Use (IFU) and notifying this information to the users through the customer letter.
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
It has been found that feather touch vinyl examination gloves are not suitable for medical/biological applications because they do not provide an effective barrier suitable for medical or biological protection.
Acción
Pro-Pac Packaging is advising retailers and distributors to immediately quarantine all Feather Touch Vinyl Examination Gloves with ARTG # 160255 printed on the box, and to contact Pro-Pac who will arrange for the stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 18/05/2017.
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
Angiodynamics, inc., the manufacturer of the 4f stiffened micro-introducer kits, has become aware of the potential with respect to the 4f sheath/dilator components for the rotating luer to detach from the dilator hub during use.Use of the affected angiodynamics stiffened micro-introducer kits may result in patient harm, including minor tissue trauma and/or minor delay in procedure to replace the device.
Acción
Medical Specialties Australia have contacted affected customers and retrieved all unused product. This action has been closed-out on 24/05/2017.
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 the local "alarms on" configuration setting on the phillips intellivue mx40 patient wearable monitor is modified from its factory default, in certain software revisions, it will disable generation and delivery of ecg alarms to the philips intellivue information center ix (piic ix) without a visual indication on the piic ix that the ecg alarms have been disabled. if the generation and delivery of ecg alarms to the information center is disabled without a corresponding visual indication at the information center, a delay in treatment could occur.
Acción
Phillips is implementing software upgrade for affected Phillips IntelliVue MX40 Patient Wearable Monitors. Users with affected devices will be contacted by a Phillips Healthcare representative for the installation of the software upgrade. In the interim, users are advised to make sure that the MX40 Patient Wearable Monitor local configuration setting ‘Alarms On’ is configured to its factory default. Philips is providing instructions to change the local configuration settings in the customer letter.
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
It was determined through the course of a post-release product investigation that the control values on an affected lot of the freelite human kappa free kit require a reassignment which is 21% lower than the value established during the manufacture of the product. with the currently assigned values, if the controls are out of range (±20% of the concentration stated), then results of the run should not be accepted, which may lead to a delay in reporting results.
Acción
In Vitro Technologies are providing users with revised values for the quality controls, which are to be used for the remainder of the shelf life of the Freelite Human Kappa Free Kit. This action has been closed out on 14 June 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
There is a potential for elevated recoveries from patient samples when using individual c packs of tina-quant hba1c gen.2. this phenomenon has been noticed across multiple lots when the reagent has inadvertently been frozen. this issue may lead to erroneously high hba1c results.
Acción
Users are to ensure the correct storage conditions of +2 to +8 °C are maintained as per IFU and if freezing was suspected, a control measurement should be performed. It was also recommended at this time to perform QC on each reagent cassette. Users are to carry out QC every 24 hr when using the cassette, and with each new cassette. If QC cannot be kept within the specified range, the respective reagent cassette should not be used for further measurement. Consider switching to the Gen.3 reagent which is less susceptible to low temperatures.
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 has been identified with the aptio automation modules. there is a possibility that the plug used to connect the automation system power source may overheat and fail. the plug used to connect to a standard power outlet is not affected.
Acción
Siemens is advising users to review customer letter with Medical Director, ensure all users are aware of the issue, return completed Response Form, retain letter with laboratory records and forward letter to those who may have received product. Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.
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
Due to a potential compromise in the packaging, there is the possibility of a breach of the sterile barrier. the use of products with this packaging defect may increase the risk of infection. there have been no reports of serious injury associated with this issue.
Acción
Covidien is advising customers to quarantine and discontinue use of devices with the affected item codes and lot numbers. Covidien will arrange for the return of unused products from the affected item codes and lots, and will issue credit for the returned devices.
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
It has been identified that the product code / lot number combination for a single lot of the device may have an incorrect instruction for use (ifu) containing a table in the description section that misidentifies the wireform and material (titanium and stainless steel). all other product labelling, including outer box and inner packaging, correctly identify the product.The potential exists that a user might inadvertently use a senomark ultracor mri 14 gauge tissue marker of the wrong material in a patient with known hypersensitivity to titanium.
Acción
Bard is providing users with instructions for use that correctly identify the wireform and material. The product can be continued to be used. 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
Stryker has identified an issue with the tha 3.1 and tha 3.1.1 software which may cause the surgeon to experience a feeling of vibration in the robotic arm during acetabular preparation. should vibration occur, the surgeon may need to reposition the arm during reaming of a planned cup position which may result in complications associated with extended surgery time of less than 15 minutes. the occurrence of this vibration will be corrected through the installation of an upgraded software version tha 3.1.1.1 on the mako system.
Acción
Stryker is advising users to inspect inventory for affected products. Users with affected product will be contacted by Stryker who will coordinate the installation of a software update as a permanent correction. In the interim, users can continue to use the affected product and mitigate the risk of vibration by following the instructions on the User Guide (PN 210555 – THA 3.1 Application User Guide, PN 212026 – THA 3.1.1 Application User Guide) and Surgical Technique (PN 210558 – THA 3.1 Surgical Technique, PN 212027 – THA 3.1.1 Surgical Technique) for proper pin placement/ securement, recommended Mako system setup and patient securement. This action has been closed-out on 18/05/2017.
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
St. jude medical (sjm) is notifying physicians of the risk of premature battery depletion associated with their icds and crt-ds manufactured before may 23, 2015. high voltage icds and crt-ds that utilise lithium-based battery chemistries are subject to lithium cluster formation during high voltage charging. depending on their location, lithium clusters may cause a short circuit that can lead to premature battery depletion. if a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy.Among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. forty-six (46) exhibited visible clusters bridging the cathode and anode causing shorting. there have been 2 deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion.
Acción
SJM is contacting physicians to provide details regarding risk and patient management recommendations. Premature battery depletion can be identified by physicians through remote monitoring or in person visits showing ERI or more advanced battery depletion.Patients may become aware when their device reaches ERI because they may feel a vibratory patient notifier alert.SJM is providing recommendations that include confirming patients can feel and recognise vibratory alerts and reaffirming the availability and usage of remote monitoring to avoid or minimise time without device therapy for bradycardia and tachycardia events. Prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion. SJM is also notifying doctors not to implant any unused affected devices that they may have in their inventory.These devices will be replaced by unaffected stock. 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
The agility mlc controller automatically adds a physical gap of 1mm (about 3mm projected to the isocenter) between opposing closed leaf pairs. therefore, leakage radiation through this gap must be correctly considered during treatment planning and dose calculation. due to a software inconsistency, the brainlab pencil beam dose calculation algorithm does not correctly regard and represent this gap if all of the following conditions are met:1. iplan rt dose v. 4.5.3 or 4.5.4 is used.2. the planning option for agility mlc is used for a treatment plan.3. the machine profile (dose profile entered in the brainlab treatment planning software) for the used agility mlc and linear accelerator combination contains a leaf shift static value different than 0mm.If the above described conditions are met, only specific plans irradiating multiple separate target volumes simultaneously with a single isocenter are affected.
Acción
Users are advised to immediately check the Leaf Shift Static value in all the machine profiles in iPlan RT Dose for an Agility MLC: Ensure that this value is set to “0 mm”. If another value is found, please change this specific value to 0 in order to permanently resolve the described potential issue. The users are also reminded of the following information which is in the current IFU:
- For any new or changed machine profiles, it is highly recommended to perform a dose verification (using a phantom) before clinical use, to ensure adequate implementation and accuracy of dose calculation.
- Patient-specific Quality Assurance of a treatment plan and verifying the dose distribution (in a
suitable phantom) is highly recommended before irradiating the patient.
Brainlab will be offering a software solution and will contact affected customers starting November 2017 to implement the update 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
It has been identified that results obtained from vitros intact parathyroid hormone (ipth) reagent packs are positively biased (i.E. falsely elevated) compared to an alternative commercially available method. ortho observed a positive bias of 40% for samples with ipth concentrations <100pg/ml when testing with vitros ipth reagent packs. this bias is consistent for all in-date lots. due to this positive bias, samples from patients with normal levels of ipth may be above the current reference interval. therefore, the reference interval as defined in the instructions for use (7. 5-53.5 pg/ml (0.8-5.7 pmol/l)) is no longer supported. the lot in which the bias originated has not been identified, so this issue affects all in-date lots and potentially lots that have expired.Due to limited availability of samples with ipth concentrations >100 pg/ml, ortho's root cause investigation of the issue is ongoing.
Acción
Ortho is advising users to immediately stop performing the VITROS Intact PTH test using VITROS Intact iPTH Reagent Packs and Calibrators, and discard Reagent Packs and Calibrators from the affected lot numbers. Ortho will issue credit for discarded lots. For results previously generated using the known affected lots, any concerns should be discussed with the Laboratory Director. For results obtained with other lots that have expired, a review of previous results may be impractical as the lot in which the bias originated has not been identified.
This action has been closed-out on 28/02/2018.