Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
This batch is being recalled as it was formulated with an excess of water, diluting the product outside the design specification. the batch met all of the release specifications, including mouse embryo assay; however, the effect of this dilution is a loss of viscosity, and creation of a hypo-osmotic environment for the sperm. this may make it difficult for the embryologist to capture the sperm, and may lead to swelling of the sperm tail.
Acción
Cook Medical is advising users to any discard remaining stock. Cook Medical will replace affected stock with a credit or replacement. This action has been closed-out on 04/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Enzygnost anti-vzv/igg lots can show a higher variation in homogeneity.
Acción
Siemens is requesting their customers to discontinue use and discard all affected lots of Enzygnost Anti-VZV/IgG. This action has been closed-out on 18/04/2017.
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 issue was caused by an unintended rounding of the median equation factors that led to inadequate number of significant digits (decimals) in the default median equation. the equation was originally introduced in lifecycle version v4.0 rev4. due to the issue, the inhibin a mom level of an unaffected population was observed to be approximately half from what it should have been. this unintended rounding error was observed internally and no customer complaints have been received.
Acción
Perkin Elmer is providing users with instructions to correct the error. Alternatively, Perkin Elmer can implement the correction at the affected site. This action has been closed-out on 19/08/2016.
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 cephalomedullary nails are packaged in double sterile barrier packaging that includes the placement of the product in a protective pouch and then into two sterile barrier trays (inner and outer). in approximately 5% of the tested samples, the outer tray was found to be compromised, however, there were no records which suggested that the sterility of the inner tray was affected. to date no complaints have been received regarding compromised packaging.
Acción
Zimmer is advising users to inspect current stock for damaged packaging and quarantine any affected units. Damaged product can be returned to Zimmer for replacement. This action has been closed-out on 22/08/2016.
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
Tornier is informing users of the known risk potentially associated with over-expansion of the small-sized mopyc stem (ptr-s7) that can result in its postoperative fatigue fracture.Although the operating technique emphasises the fact that stem expansion should only be performed when rotation instability is observed in the shaft, tornier noticed that the stems which were subject to fracture were over-expanded. tornier is providing users with a surgical technique addendum to emphasise this key point of the operating technique and to avoid unnecessary stem expansion that may be harmful for the patient.
Acción
Tornier is providing users with a Surgical Technique Addendum to include further information regarding the risks of over expansion. This action has been closed-out on 25/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An anomaly has been identified with the varisource ix control software. in the event a forced logoff occurs while the dummy wire is extended during a treatment session, the partial fraction generated by the system will be incorrect. the control software does not differentiate the re-start dummy sweep from the dummy sweep at the beginning of the treatment session. the control software assumes no treatment has been delivered. the partial fraction generated will be equivalent to the original full fraction. if this partial fraction is treated, this would result in re-treatment of any dwell positions actually delivered prior to the session interrupt and result in a dose greater than intended. the treatment recovery report will incorrectly indicate that no dwell positions have been treated. both the treatment delivery report and the treatment history report do correctly indicate the dwell positions treated.There have been no reports of patient injury due to this issue.
Acción
Varian Medical Systems is developing a technical correction for this issue. A Technical Service representative will contact the affected hospital when this correction is available to schedule its installation. In the interim a workaround is provided 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
A software defect has been identified on newly installed au480 systems with software version 1.81. the defect may generate incorrect test results for 2 step method assays on au480 systems configured with closed channels. the software defect occurs when edit and then confirm are pressed on the specific test parameters screen of closed channels. the result is that the measuring point-2 settings will be deleted. the measuring point 2 settings are used for sample blank adjustments for 2 step methods.For samples which may have lih (lipemia, icterus, hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels.
Acción
A Beckman Coulter FSE will visit each laboratory and change the closed channels to open channels. A set of action steps and associated instructions is also provided in the Customer Letter which Laboratories can use to determine if they have been affected. This action has been closed-out on 22/08/2016.
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
Cook medical is initiating a recall of all lots in distribution following reports of catheter tip splits and/or separation. potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
Acción
Cook Medical is advising users to inspect and quarantine any affected lots for return to Cook Medical.
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 supplier has advised they are not authorised to supply the kit outside of the us, however there is no health risk associated with use of the kit.
Acción
In Vitro Techologies is advising users to stop using the product and discard any remaining stock, for credit. This action has been closed-out on 07/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Beckman coulter has confirmed that n-acetyl cysteine (nac) used in the treatment of acetaminophen overdose may cause assay interference when administered in therapeutic concentrations with assays using the trinder chemical pathways; enzymatic creatinine (cr-e) and uric acid (uric). nac interference may lead to falsely low results for uric acid and creatinine in patients who are concurrently being treated for acetaminophen overdose with nac.
Acción
Beckman Coulter is amending the INTERFERENCES section of the Chemistry Information Sheets to include N-Actel Cysteine. There is no requirement to review previously generated results. This action has been closed-out on 04/03/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker has received customer complaints regarding the triathlon mis modular distal capture device disassociating during use. this may result in one or more of the following potential patient harms: · complications associated with extended surgery time· inflammation / inflammatory response.· revision surgery to retrieve loose spring.
Acción
Stryker is advising users to inspect stock and quarantine any affected units. Affected units will be replaced with unaffected stock. This action has beem closed-out on 05/12/2016.
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 only image sets that are supported by the brainlab radiation treatment planning software even when containing varying calibrations of pixel values in between image slices are ct image sets & pet image sets normalised to suv with suv also loaded in and displayed by the brainlab swif such an unsupported image set is used the same pixel value calibration as contained in the middle image slice of the set to all slices is applied. in a pet image set uniform calibrated pixels might then have a different activity value, thus displayed with a different brightness and colour, compared to the image slices as displayed by the scanner using varying calibrations. if this effect occurs when using an unsupported image set, it can be misleading to the user during treatment planning and result in an incorrect definition of vols of interest in the planning s/w. the objects created for these vols of interest might differ in location or dimension from the actual desired definition of the structure.
Acción
Brainlab will provide a software solution with the corresponding new feature for affected iPlan RT / iPlan RT Image customers to prevent the described scenario from occurring. In the interim, customers are advised to:
- Except for CT and PET used with SUV, only load and use image sets in iPlan RT / iPlan RT Imagethat have the same pixel value calibration for all images of the set.
- Before using image datasets loaded into the Brainlab Radiation Treatment Planning Software, always compare the images displayed in the Brainlab application to the images as displayed by the imaging device (scanner). Delete and do not use the image sets within iPlan RT in case any deviation is detected and contact Brainlab support.
Brainlab will not provide a software update for BrainSCAN. Brainlab strongly recommends customers still using BrainSCAN clinically to phase out the use of this software as soon as possible but in no event later than January 2016.
This action has been closed-out on 02/12/2016.
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
1) in version 5.10.01, the isodose control 100% isodose value (second in the list) was linked to the dose normalisation (dn) value so users would always have a known normalisation value linked to 100% when in relative mode. when the 100% isodose value is edited on the isodose control, the dn is automatically updated. if the user does not notice this update & then rescales to a relative isoline & does not read the dn value displayed on the rescale bar, the rescale could be other than intended. 2) in version 5.10.00 or greater, when the user optimises, then changes the bolus assignment of the beams, and then selects “calculate” (not “optimize” again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect. skin doses could either be higher of lower than intended and this increase or decrease in dose could exceed 5%.
Acción
1) The workaround is to only assign one value greater than 100% as the system is defaulted so the 100% isodose line and dose normalisation values are not affected. When rescaling, the dose normalisation value is displayed next to the re-scale value being entered by the user.
2) There is no workaround using the described workflow. However, the problem can be avoided by changing any bolus assignment before optimisation.
Both problems will be resolved in Monaco Patch Release 5.10.02. This action has been closed-out on 22/08/2016.
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 technical investigation has confirmed that the affected lot contains insufficient concentration of penicillin. continued use of this product could result in the incorrect reporting of minimum inhibitory concentration against penicillin.
Acción
Thermo Fisher is advising users to inspect stocks and remove from use any remaining units of the affected lot number. Affected stock can be returned or destroyed for credit.
Results issued with the affected lot number should be reviewed against case histories, other results and other relevant individual data. This action has been closed-out on 25/08/2016.
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
Temozolomide may cause interference in assays using nad(h) or nadp(h). this has been confirmed in assays for gldh, ckmb and nh3, depending on the analyser used. it has been determined that the interference occurs at either very low analyte, or too high drug concentrations. these internal investigations were carried out with the therapeutic peak plasma concentration of 0.013 mg/ml temozolomide. higher drug concentrations were not systematically tested, because no literature reference for plasma concentrations > 0.013 mg/ml was found. the maximum bias for assays which showed interference at 0.013 mg/ml temozolomide is shown below:parameter % biasgldh + 62%ckmb - 31%nh3 + 36%this interference may results in falsely high or low results.
Acción
Roche is advising laboratories of the potential drug interference. Test instructions for use are in the process of being updated. This action has been closed-out on 19/08/2016.
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
During stability testing at test point 9 months, with lmx lot 3002350, immucor observed false positive results with a single sample. the sample is expected to test negative for both hla class i and class ii. the sample gave a qualitative result of ci (-), cii (+), indicating a false positive for hla class ii.
Acción
Diagnostic Solutions is advising users to destroy any remaining stocks of the affected lots.
It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 19/08/2016.
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
Welch allyn has been made aware that the kleenspec 788 corded illuminator has the potential to be incorrectly connected to a commonly available ac power cord instead of the illuminator low voltage transformer power cord. this may result in a shattered lamp and a potential electric shock hazard. commonly available ac line power cords do not have an integrated wall transformer and therefore, the electrical current from the outlet is fully transferred into the device. there have been no associated injuries, but the misconnection can be reproduced. for example, the illuminator cord connector may fit into ac power cords from common consumer equipment, such as laptops, and other medical devices that have similar power cord connector.
Acción
Welch Allyn is providing users with additional labelling to place on the cords to remind users to only connect the Illuminator with the corresponding corded wall transformer. This action has been closed-out on 22/08/2016.
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
Internal investigations by roche diagnostics have uncovered the potential for incorrect slide staining (ihc/ish) to occur on the benchmark ultra instrument or discovery ultra instrument running ventana system software (vss) 11.9 or higher, due to the possibility of a duplicate keycode error. the embedded software for the barcode reader has an identified issue, which on presentation of this error may result in two slides erroneously receiving the same stain protocol regardless of what should have been indicated in the software for that keycode. the barcode reader fails to purge previously read barcode information and applies the same protocol details to a subsequent slide.
Acción
Roche is advising users to use same-slide controls as per the package insert and review run reports at the end of each run to ensure the intended staining protocol was used on each slide. Additionally, ensure each host has an adequate keycode range allocated. Roche will be performing a software upgrade as a permanent correction. This action has been closed-out on 26/08/2016.
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
Investigations have confirmed that certain lots of quidel sofia legionella fia may give a false positive reading in some cases some cases due to rheumatoid-like factors present in the urine of some patient specimens. revised instructions for use (ifu) are being provided which specifically references instances where these rheumatoid-like factors may be present and recommends a method for testing these particular patient samples.
Acción
Thermo Fisher is providing users with a revised IFU which includes instructions on the treatment of samples when a false positive is suspected.
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 determined that the access cea reagent packs were filled incorrectly. these packs contain insufficient quantity of reagents in one of the pack wells. the impact is dependent upon the instrument and software version installed at the time the reagent lot was in use: access 2 systems, software version 3.3.1 or lower, and access 2i systems, software version 6.1 or lower: - the instrument may have generated incorrect results of 0.0 ng/ml. all other results greater than 0.0 ng/ml are not affected by this issue and are correct. access 2 systems, software version 3.4.2 and access 2i systems, software version 6.2.2 or higher: - the affected packs would be detected by process monitoring, and the pack disabled by the instrument. no patient results generated. unicel dxi systems with all software versions: - the packs wouldbe detected by reagent pack monitoring, and the pack disabled by the instrument. no patient results generated.
Acción
Beckman Coulter is advising users to discard any remaining stocks of the affected lots.
Beckman Coulter is recommending users review patients results that were reported as 0.0 ng/mL and did not match the clinical status of the patient, and advise clinicians at the discretion of the Laboratory Director. A software upgrade for Access systems to version 3.4.2 and Access 2i to version 6.2.2 rectifies this issue. This action has been closed-out on 02/05/2017.
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
As a follow-up to the previous communication in 2014 (tga ref: rc-2014-rn-00774-1), physio-control is correcting a software malfunction that may contribute to defibrillator batteries not being replaced when required.Physio-control australia has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock and deliver therapy.The operating instructions provided with the device may be confusing to some customers, which has contributed to customers not replacing their battery when required. also, a software malfunction in the lifepak 1000 defibrillator that also contributes to some customers not replacing their battery when required. this results in the readiness display indicating a low battery charge when it should indicate a very low battery charge.
Acción
Physio-Control will be implementing a software update in all affected devices over the next year. Updates to customer devices will be prioritised based on the age of the devices as well as the feedback provided in the response to the confirmation sheet attached with the customer letter.
In the interim, customers are advised that it is critically important to understand what the device and battery indicators mean on the defibrillator and what actions needs to be undertaken. At any time the battery charge can be verified by the instructions provided in the Operating Instructions. Batteries that are at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the OK symbol is present.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Beckman coulter has determined that some access free t3 reagent packs were filled incorrectly. beckman coulter has determined and confirmed that thirty-two access free t3 reagent packs are affected by this issue. these packs contained insufficient quantity of reagents in one or more of the pack wells. this may give rise to inaccurate test results and/or delays in therapy.There has been no report of death or injury related to this defect.
Acción
Customers are asked to discard affected lots numbers and to initiate a review of patient results as per the discretion of the Medical Director. This action has closed-out on 19/08/2016.
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 identified multiple issues with the advia centaur xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) and v1.0.2 (bundle 1.0.1086 smn 11219806).
Acción
Users are provided a detailed workaround in the customer letter whilst a software upgrade is being scheduled.
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 potential for a sterile breach in the pouch material was discovered during standard internal packaging tests. the pouch seal breach could potentially result in compromised sterility of the product. following the instructions for use (ifu) would reduce the risk of potential patient harm if issue was easily detectable but in most cases it is not. there have been no reports of adverse patient events related to this issue.
Acción
Customers are advised to remove and quarantine and return all units of the Amphirion Deep Balloon Catheter that remain in their inventory. Patients who have received treatment with an Amphirion Deep PTA Balloon Dilation Catheter affected by this recall should continue to be monitored in accordance with the standard practice. This action has been closed-out on 22/08/2016.