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 identified an issue with rapidpoint 500 blood gas analysers with v2.4 software. there is a potential to misassign patient demographic information (last name, first name, gender, or date of birth) when the patient id field is left “blank” on multiple patient samples and a recall of the patient information is initiated. as stated in the rapidpoint 500 operators guide, the patient id field is a “required” field, and the patient id field is set as “required” when the rapidpoint 500 analyser is shipped from siemens. there is a risk to health based upon the potential misclassification of a patient as having falsely abnormal test results receiving additional diagnostic testing and treatment, as well as the risk of a patient who has abnormal results being incorrectly identified as having normal results based upon incorrect sample identification.
Acción
Siemens Healthcare is currently developing a software update to address this issue and will be providing new information as it becomes available. In the interim, Siemens is advising users to maintain the Patient ID field as enabled and a “required” Patient Demographic entry on their RAPIDPoint 500 analyser. If the Patient ID field on the RAPIDPoint 500 analyser is not set as “required,” reset it to “required” by following the instructions provided in the customer letter. If the laboratory has run samples from multiple patients with the Patient ID field blank, Siemens recommends a review of those previously generated results.
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
Beckman coulter has been informed that a study completed by the french competent authority ansm showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu). the ansm’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the access br monitor url. in this preliminary study, at the cutoff of 31.3 u/ml designated in the access br monitor ifu, the assay achieved a sensitivity of 63% and a specificity of 100% for patients in non-remission.As a result, beckman coulter is evaluating the access br monitor cutoff. the conclusions of this evaluation are planned to be available by the third quarter of 2017.
Acción
Beckman Coulter is advising users that they are currently evaluating the Access BR Monitor cutoff. Users are reminded of the limitations of the assay which are included the current IFU and detailed in the customer letter. These relate to the intended use of the assay as an aid in the management of breast cancer patients and not as a screening tool, the interpretation of CA 15-3 antigen concentration results and the laboratory's establishment of reference ranges to assure proper representation of specific populations.
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 manufacturer quantel medical has become aware of an issue with the micropulse mode of the easyret laser (qm-pabx0017, serial number 155) in software version 1.03. if the validation key of the intermediate window for treatment lens and spot size selection is pressed twice when selecting the micropulse mode, a software bug leading to the delivery of an erroneous level of energy corresponding to a 100% duty cycle when in treatment session will be created. this issue could cause photocoagulation of the retina in patients.
Acción
Device Technologies Australia (DTA) is advising users to discontinue use of the MicroPulse mode on the device until the software update in version 1.04 has been completed by a DTA representative.
This action has been closed-out on 15/03/2018.
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
For a single product lot, teleflex medical has identified a labelling error on the boxes which contain six individually packaged and labelled device units. some boxes are labelled as containing visistat wide devices, when they in fact contain visistat regular devices. the individual units are correctly labelled with the actual size of the device. the labelling error applies only to some units of sales boxes in the affected lot number. it is unlikely that the use of these products will result in any adverse health consequences, although it is possible there could be a delay of the procedure.
Acción
Teleflex is advising users of the labelling error, and requesting that they place a copy of the customer letter detailing the issue with the affected lot.
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 manufacturer, handicare, has identified the possibility that the carina mobile lift could be mounted incorrectly by users in two respects. namely, the lift arm and actuator could be incorrectly mounted and/or the mast with lift arm could be incorrectly mounted.If the connection between lift arm and actuator is incorrectly mounted, there is a possibility that a metal part on top of the actuator (i.E. piston rod eye flange) fractures when subjected to certain weight loads. in the event that the mast is not fully inserted into the mast base and standing upright in a vertical position, there is a possibility that the mast falls forward when subjected to weight load. therefore, there is a risk that an incorrectly mounted mobile lift would cause injury upon use.
Acción
Active Medical Supplies is requesting users to follow the additional instructions regarding the inspection of the connection between the lift arm and actuator as well as the positioning of the mast to prevent incorrect mounting of the mobile lifts. The instructions are contained in Annexes A and B (respectively) of the recall notification and are intended to supplement the Instructions for Use (IFU). Users are advised that the updated IFU is available for download from the manufacturer's 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
Abbott vascular advises that, effective immediately, the absorb bioresorbable vascular scaffold (bvs) system will only be available for use in clinical registry and special access settings. data from recent analyses have demonstrated that optimal implantation technique is critical to achieving good clinical outcomes. limiting use of this device to select hospitals/institutions will enable abbott to collect additional data and monitor implantation techniques. in light of recent concerns over elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis, abbott vascular awaits further data to confirm whether improved implantation techniques will mitigate these higher event rates.
Acción
Abbott Vascular has removed the product from the ARTG and is recalling all stock from the market until further notice. For further information please see https://www.tga.gov.au/alert/absorb-bioresorbable-vascular-scaffold-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
Abbott has identified that architect shbg results generated with the potassium edta specimen tube type may demonstrate a negative shift relative to results generated with serum. shbg dimer destabilisation in edta could result in low shbg measurements by immunoassay. in other words, there is a potential for falsely decreased architect shbg results to be generated when using the architect shbg assay with the potassium edta specimen tube type. internal studies have determined the use of the potassium edta specimen tube type may result in a decrease in shbg concentration values of greater than 20% when compared with serum collected in serum tubes. the shift was observed across the full analytical range of the assay. as a result, an increase in free androgen index / free testosterone index calculations of up to 30% may also be observed when using potassium edta specimen tubes.
Acción
Abbott Diagnostics is advising users to immediately discontinue the use of the Potassium EDTA specimen tube type with the ARCHITECT SHBG assay. Users are requested to review the recall notification with their Medical Director to ensure that they are aware of this issue and to determine if a review of previously generated results using the Potassium EDTA specimen tube type is required.
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
Inova has identified an issue with two lots of the ez-load lens delivery system ez-28v, an intraocular lens inserter used to insert sofport intraocular lenses (iols). some inserters have been found to have a hook-like flash located near the tip area. this flash catches the leading haptic causing a kink. whilst mildly bent haptics can be restored to acceptable configuration intra-operatively using surgical instruments, a severely kinked haptic which cannot be restored can result in injury to the intraocular structures.
Acción
iNova is advising users to inspect their stock of EZ-Load Lens Delivery System (EZ-28V) immediately and quarantine any affected lots. iNova will arrange for stock collection and will issue credit for returned stock.
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
In sensis systems, a computer that is extremely dusty can cause problems when starting the system. in rare cases, it can cause the sensis to fail. the system's functions cannot be used in the event of a failure and as a result, clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
Acción
Siemens is currently working on a solution and will update users in the second quarter of 2017. In the interim, users are requested to conduct a system check to ensure that the system is functioning properly prior to performing an examination. In the event that the system fails to start within the time and parameters described in the operator manual, users are requested to notify Siemens Service, and terminate, restart or transfer clinical treatment to a functioning system. Users are to ensure that standard emergency processes are in place for implementation in the event of a system failure.
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 manufacturer nortec medical have advised that the keyhole clips on pivot, pivot hygiene, pivot hammock and tony pringle clip style sling may break. there have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. these keyhole clips are the black plastic component which is attached to the sling by means of a webbing strap threaded through a slot. the affected clips have all broken at the slot.If the clip on the sling were to fail under load (whilst a patient is being transferred), the patient will fall from the hoist.
Acción
Active Medical requests that all recalled sling/s must be removed from service and disposed of.
Users are requested to return a completed Urgent Medical Device Recall Notification form (provided with the Customer letter) and return it to Active Medical Supplies at recalls@activemedicalsupplies.com.au or fax to (07) 3899 8825 or post to Active Medical Supplies – Quality Assurance PO BOX 3392 TINGALPA QLD 4173. Replacement slings will be made available to affected customers.
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
Biomérieux have identified a potential issue for specific product lots that is related to the white pouch which contains vitek 2 test cards. the integrity of some of the pouches may be compromised. a compromised test card pouch can impact card reagents due to the entry of moisture. the white pouch is composed of 5 layers of material, 4 of which are clear. all 5 layers must be compromised for a pouch to potentially allow moisture to enter the pouch. based on internal testing, approximately 20% of card pouches exhibited a visual defect, which is a small puncture or tear in the packaging at the "stitch seal". however, 1 in 200 (0.5%) card pouches that passed careful visual inspection failed further integrity tests.The compromised test card pouch integrity could yield false resistance for antibiotics on the ast panel, cause a false negative extended-spectrum beta-lactamase (esbl) test or result in a false positive urea (ure) reaction on id cards.
Acción
bioMérieux is advising users to identify impacted lots and visually inspect the test card pouches on both sides for the defect. The defect is a small puncture or tear in the packaging at the "stitch seal". If the defect is observed, destroy the associated test card(s) and contact bioMérieux for credit or replacement. If the defect is not observed, continue testing as per normal procedure, but increase monitoring for potential testing errors, as visual inspection may not identify all affected ID/AST cards. Repeat testing if you observe results potentially indicative of a pouch defect, as detailed in the customer letter. If concerns exist after repeat testing, alternative methods of establishing drug susceptibility should be used. A look-back of results previously generated with the affected lots is recommended.
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 possibility that due to a packaging error, 20ga vitrectomy cutters may be found in a 25ga package and 25ga vitrectomy cutters may be found in a 20ga package. use of a vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.
Acción
AMO Australia is advising users to immediately stop using and remove from their inventory all affected lots of the Vitrectomy Cutter. AMO will arrange for return of affected product and replacement.
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
Bio-rad laboratories have been made aware that samples of the product diamed q.C. system, (ihd lot 45950 46 1 and 45950 47 1) show excessive haemolysis in samples 1 and 4 and weakly in sample 2. haemolysed cells may continue to be used as long as they give the expected results. internal tests performed by bio-rad have confirmed that a clear result is returned with manual testing and on the saxo-swing, ih-1000 with the haemolysed qc samples. with ih-500 you may observe uninterpretable results on reverse grouping. in this case, please use another sample to perform the reverse grouping. note: tests involving serum 1 and serum 2 are in no way affected. the current situation has shown that the haemolysed lots will still allow the customers to perform qc testing for the following applications:- typing abo/d and phenotype rh kell- antibody screening and identification- compatibility testing.
Acción
1. Distribute this information with in your facility to all those who need to be aware of this notice
2. Bio-Rad kindly requests you to discard all remaining kits of these affected lots, once replacements have been received. Bio-Rad will provide a replacement once the supplied response form is received..
3. Complete and return the supplied customer response form to Bio-Rad Laboratories as acknowledgment of receipt of this important information, even in the absence of stock.
4. If you have forwarded any product within your facility, please provide a copy of this letter to them and advise Bio-Rad Laboratories.
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
Amo has identified the remote possibility that certain healon 0.55ml solutions in the affected lot may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. use of ovd solutions with glass particles could potentially lead to intraocular injury. to date, no patient injuries have been reported to amo in connection with any of the affected healon 0.55ml.
Acción
AMO Australia is advising users to immediately stop using and remove the affected Healon 0.55ml lot from their inventory. Distributors are to stop shipping this lot. Product is to be returned to AMO for replacement.
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 gmbh has received a customer complaint that the lag screw would not completely cannulate as the guide wire would not pass through the cannula of the screw. no harm was reported. it was found on investigation that the obstruction is related to a metal burr in the cannula of the screw which was not removed during manufacturing causing obstruction. the obstruction in the cannula of the screw is easily recognisable for the user. in most cases the surgeon would detect significant resistance when passing the lag screw over the guide wire before it touches the skin and would not continue using the screw. a different screw would be available and used, resulting in a minor delay in surgery of <15 minutes. if the surgeon does not notice or ignores the resistance, then surgical complications related to the guide wire being stuck in the cannulated screw and/or the guide wire being pushed out of the femoral head could theoretically occur.
Acción
Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate the return and replacement of the product.
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 found that there is the potential for loosening of the safety clips from the intended position on the quick release mechanism of the transport struts. in the case of no safety clip and/or overloading, the frame may loosen, bend or break in time, causing frame stability collapse.
Acción
Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate return of the product and provide credit. Clinicians are advised to inspect if the Safety Clips are still in place when patients come in for routine follow up examination and replace the Safety Clips, and to consider contacting patients that do not show up for routine follow up examination. The need to replace the entire Hoffmann LRF Bone Transport if indicated should also be considered.
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 two issues related to the v-lyte integrated multisensor technology (imt) system. the issues regarding the v-lyte dilution check solution and the v-lyte imt system are:1. dilution check relative bias failures - a high rate of dilution check relative bias failures of greater than 2% when using specific lots of v-lyte dilution check solution; and2. integrated multisensor (imt) urine sodium drift - elevated urine sodium quality control (qc) exceeding acceptable qc ranges with the dimension vista imt system. a greater urine sodium drift with urine qc than urine patient samples has been observed. however, not all imt sensors exhibit the described urine sodium qc drift.
Acción
1) For repeated dilution check relative bias failures, Siemens is advising users to contact Customer Care Centre for further assistance. 2) For repeated elevated urine sodium QC drifts, users are advised to load a new Integrated Multisensor Technology (IMT) sensor in addition to coordinating a combination of the steps detailed in the recall letter to minimise or eliminate the drift of urine sodium QC and patient samples as well as to prevent premature sensor replacement and additional troubleshooting. Users are requested to review the letter with their Medical Director.
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 regarding the use of the arctic sun 5000 temperature management system, in excess of 2,000 system hours, without conducting preventative maintenance has been identified. this issue may result in failure of certain components, in particular, the mixing pump of the system. the mixing pump runs continuously during operation and its failure may cause the system to cease functioning as intended. therefore, resulting in no availability of cooling or rewarming therapy for the patient. to date, bard australia has not received adverse reports of injuries or diseases related to this issue.
Acción
Bard Australia is updating the Operators Manual and the Service Manual for the ARCTIC SUN 5000 Temperature Management System. Customers are advised to examine their inventory for affected devices to determine their total system hours of use by following the instructions detailed in the recall letter. Customers with devices approaching or exceeding 2,000 system hours are requested to contact their local Bard representative for further information. Customers with devices that have less than 2,000 hours are reminded to address potential issues before their occurrence in order to maintain device availability. In the event of a device failure, customers are advised to utilise alternative conventional methods for patient temperature control.
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 have been two local reports of the mouth piece part of the device being dislodged into the throats of patients. the mouth piece is manufactured to be manually removed if clinically necessary. the results of an investigation revealed that it occurred due to a high level of patient agitation. there is a potential risk of asphyxiation if this problem occurs.
Acción
Device Technologies is updating the IFU (Instructions for Use) to state that it should only be used on patients who can tolerate the adapter and that the oral breath collector may come loose under extreme conditions and could be aspirated.
Users are also requested to retain a copy of their recall letter with the IFU of the affected device.
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
Resulting from a post-market internal investigation, mölnlycke has identified a potential safety issue regarding the current sterilisation validation for the brennen skin graft mesher. with the current sterilisation instructions contained in the instructions for use (ifu), the sterility of the mesher cannot be guaranteed following a sterilisation cycle carried out according to those instructions. given the sterility of the brennen skin graft mesher cannot be guaranteed there is a risk for possible contamination, which may lead to infection. mölnlycke confirms that no product, patient or user complaints have been reported to date for products in australia regarding this issue.
Acción
Mölnlycke is advising users to immediately stop using the Brennen Skin Graft Mesher and apply the tag (i.e. label) provided by Mölnlycke to the device, or otherwise remove the device from service using applicable labelling and/or quarantine measures under the respective in house quality management system. The tag supplied states that the device is out of service and should not be used. Once the new sterilisation parameters have been confirmed by the manufacturer, through further validation testing during May, Mölnlycke will send users the updated IFU defining the new Sterilisation Procedure. This is estimated to occur in 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
The manufacturer vascular solutions (vsi), through an internal investigation has concluded there is the potential for excess material used to manufacture specific venture catheters to be present within the inner lumen of the distal catheter tip. it is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient. to date, the manufacturer has received no reports of adverse patient events related to this issue.
Acción
Pyramed is advising users to immediately cease use of and quarantine the affected units. Pyramed will arrange for the return of affected devices and credit for unused devices after their return.
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 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance.There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices.
Acción
Users are requested to:
1. Review the list provided in the customer letter and examine inventory immediately to identify; and quarantine any affected products.
2. Complete and return the Acknowledgement and Receipt form provided as soon as possible.
Users are further advised that supply of these products will be discontinued in Australia.
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 possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. the events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.In most cases, system flags and/or messages have accompanied the erroneous results, indicating the need to review the results. in rare instances, system flags and/or messages might be absent.
Acción
Users are requested to:
1. Use all available features to assess patient results, including reference ranges, action and critical limits, instrument system flags, codes, messages, delta checks, and decision rules;
2. Follow all Instructions for Use (IFU) pertaining to flow cell error and warning messages, and ensure daily Shutdown is performed;
3. Follow your laboratory’s standard operating procedure for confirming unexpected results;
4. Communicate to your Laboratory Medical Director the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features; and
5. Consult with your Medical Director to determine if a retrospective review of results is warranted.
In the interim, Beckman Coulter is working on a permanent resolution to detect and flag these unexpected light scatter patterns.