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
Olympus has updated the instructions for use (ifu) for the hf resection electrodes. the ifu has been updated to include new contraindications, warnings and safety information.
Acción
Olympus is asking customers to:
1. Inspect inventory and replace any existing IFUs supplied with the device as per the list on Appendix A with the latest version provided in the customer letter;
2. Ensure all personnel are trained and/or familiarised themselves with the added contraindications, warnings and safety information as stated. Do not hesitate to contact your local Olympus Sales Specialist to organise additional training;
3. Complete the supplied reply form as per the instructions given;
4. If you have distributed or transferred any of the affected items from your facility to another, please forward this recall notice and also please notify Olympus so that we can follow up with that facility directly;
5. If you require additional hard/electronic copies of the IFU, please email RA@Olympus.com.au; and
6. If you have any queries or concerns in relation to this matter please do not hesitate to contact Olympus Customer Operations on 1300 657 699 or email RA@Olympus.com.au.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic has become aware of instances where spine clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient’s spinous process. when the spine clamp is forced open beyond its intended limits, a component (captive washer) may break off. the washer could then be inadvertently left behind in a patient’s body if the breakage occurs during the procedure. if the washer is missing from the device, the spine clamp cannot be re-opened after placement on the spinous process.Medtronic has received six reports where unintended removal of spinous process occurred when attempting to detach the spine clamp. the unintended removal of spinous process can lead to damage of adjacent vertebra and cause premature degradation.
Acción
Medtronic is providing an interim workaround for users via the Customer Letter. A new version of the clamps with a design mitigation will be distributed as a permanent correction once available.
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 three complaints regarding the jts drive unit. these relate to the potential for utilisation of the jts grower drive in the incorrect orientation in relation to the limb entry point of the device and the potential to select incorrect settings for the extension procedure. as a result, the prostheses in such cases failed to extend as intended.New labelling is to be provided, and a quick start guide attached to the device, along with revisions to the limb lengthening protocol & operation manual to reference these labelling modifications. these modifications/ updates are to clarify the correct orientation in relation to the limb entry point of the device.
Acción
Stryker is requesting:
1. Users of this Medical Device forward the supplied notice to all those individuals who need to be aware within their organisation;
2. Inspect inventory for the impacted JTS Drive Unit and quarantine it immediately;
3. Contact their local Stryker representative to coordinate the return of any affected product you may have;
4. Complete the supplied “Medical Device Recall Notification Response” form even if they do not have any affected product. Return the form to Stryker by fax on (02) 9467 1325 or electronically via email to recalls@stryker.com;
5. If any affected stock could have been transferred from their hospital to another location, please immediately let them know of this recall and notify Stryker
6. If customers have disposed of any affected units, provide the item and lot numbers of the disposed product to Stryker via email account recalls@stryker.com.
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 application sheets provided by the manufacturer microgenics for expanded use of some assays are inadequate. specifically, the appropriate validation data for the expanded use of these assays, as indicated in the instructions for use (ifu) when not used on manufacturer approved analysers, is inadequate. in addition, microgenics did not clearly state in these application sheets that the parameters provided are only to be used as starting points and that each assay setting needs to be validated individually by the user.Thus the information given on the specific application sheets for use with non-microgenics approved analysers may be ineffective. it is possible that assays not validated for use with other instrument platforms could potentially lead to erroneously low or high test results.
Acción
Beckman Coulter is requesting Customers:
1. Immediately check if they are using any of the affected Application Sheets on the platforms as listed in the letter supplied; and
2. Discontinue use of the affected Application Sheets. Review their internal assay validations to determine if the current instrument settings using these Assays require additional action within the clinical laboratory setting. If customers have performed a compliant self-validation of a particular Assay on a specific instrument in accordance with applicable laboratory certifications or requirements, they may be able to continue to use that Assay on the corresponding instrument.
Consult a qualified healthcare professional as appropriate. If they have performed a compliant self-validation, note that on the supplied Vigilance Response Form.
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
Smith & nephew has identified a labelling error with specific models and batches of thin and radial osteotome blades. the expiration dates on the label exceed the actual validated expiration date of the outer sterile barrier packaging. affected devices have expiration dates based on a 10 year packaging shelf-life where the actual validated shelf life of the outer pouch packaging is 5 years. this could potentially result in the outside of the inner tray packaging being non-sterile, potentially contaminating the sterile field.The inner tray packaging is validated for a 10 year shelf-life and to date no adverse events have been associated with this issue.
Acción
Smith & Nephew is requesting customers:
1. Immediately locate and quarantine affected devices;
2. If any of the recalled products could have been transferred from their hospital to another hospital please provide copies of the recall notice to all users;
3. The supplied acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free)
4. If you have affected product to return, Smith & Nephew representatives will be in contact with customers once the Recall Acknowledgement Form has been received to arrange for affected products to be returned. Please keep a copy of the completed Recall Acknowledgement form with any affected stock to be returned; and
5. Replacement products will be arranged once Smith & Nephew receive the Recall Acknowledgement Form.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ge healthcare observed during a pre-installation checkout procedure that an impedance respiration apnea alarm could not be produced with pdm v2.6 and carescape b850 v 2.0.7 host monitor software. the pdm v2.6 has been limited to a small number of customer sites. the issue was identified in the biomed shop during check out. to date, no actual reported patient incidents of a missed apnea alarm with pdm v.2.6 have been reported.
Acción
GE Healthcare will correct all affected products at no cost to users. A GE Healthcare representative will contact each affected site to arrange for the correction to take place.
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 received a customer complaint regarding qc failures (diameter out of range - too high) when testing atcc strains for antibiotic susceptibility test by disk diffusion method when using mhe agar. it could be determined that the use of the medium mhe by disk diffusion method with the antibiotics belonging to cyclines and aminosides classes could potentially lead to failure to quality control test (out of range high) and false susceptible result for clinical isolates (whatever the strain that could be tested) instead of resistant results. as a result there is a potential performance issue on strain categorisation that could lead to false susceptible result for antibiotics belonging to cyclines and aminosides classes when testing patients’ samples’ for antibiotic susceptibility test by disk method using specific lots of mhe agar.
Acción
bioMérieux is requesting customers:
1. Distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred our product;
2. Laboratories should stop using the specific lots of MHE agar ref. 04091, 413822 , segregate the product and discard/ dispose appropriately under laboratory guidelines;
3. Among tests previously performed, identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant;
4. Complete and return the acknowledgement form to qa.anz@biomerieux.com to confirm receipt; and
5. Contact your local bioMérieux representative for product compensation if needed.
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
Zimmer biomet has identified that specific dental products have had several parts shipped to the customer with only standard instruction for use (ifus). all the products were missing supplemental ifus.There is no significant risk to patients as this issue does not affect any fit, form or function of the product. nonetheless a delay in surgery could occur while waiting for additional information regarding the product.
Acción
Zimmer Biomet is providing users with the supplement IFU's.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips has identified that the protecting earth (pe) cable between a motion controller and the pe star point was not installed on the affected product.The lack of this aforementioned protective earth cable makes the system not compliant with the iec60601-1 standard for protective earthing, however there is no risk for patients / operators / users since the frame is connected to protective earth (pe) and the unit involved is shielded with a cover.The relevant parts are in the technical (equipment) room and therefore not accessible for patients. to date, philips is not aware of any injuries that may have occurred as result of this situation.
Acción
Philips is requesting customers:
1. Read the supplied notice;
2. Place the notice with the documentation of the system until this correction has been implemented; and
3. Complete the supplied response form and return it to Philips via fax/email within 3 business days of receiving 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
Philips originally advised of electrical interference via sync cables (tga ref: rc-2014-rn-01291-1), where affected cables were replaced. philips is now advising users to cease using and dispose of sync cables and ecg out cables, as when using a sync cable or ecg out cable with the heartstart mrx or heartstart xl, eft noise may be mistaken as an r-wave. if this occurs when performing synchronised cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronised to eft noise instead of the r-wave of the patient’s actual ecg.
Acción
Philips is requesting users read the supplied notice and then:
1. Remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the acknowledgement form, which should be returned to Philips;
2. There are 3 options for the user to synchronise the MRx or XL+ monitor/defibrillators, so the synchronisation function is not lost. In summary, these methods are:
-The shock pads ECG can be used for synchronisation.
-If the user places or replaced 3 leads ECG pads, the resulting ECG can be used for synchronisation.
-The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy.
For further information, the customer should refer to the Instructions for Use that describe the recommended approach for performing cardioversion.
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 incubation bath is cleaned or cuvettes replaced on the cobas c 501/502 modules during routine monthly maintenance, the usm cover 3 is removed. whilst loosening one of the thumb screws on this cover, an instrument operator cut their thumb on the 90-degree edge of the thumb screw bracket.Given the cobas c 501 modules and cobas c 502 modules share the same hardware, roche diagnostics has, as a precaution, decided to inform and request operators of both systems to perform the related maintenance task with special caution, to prevent any further occurrence.Although the design of the usm cover 3 is according to the manufacturer’s specification, and the 90-degree edge is clearly visible, a medical risk due to an injury cannot be entirely excluded. roche has received only one complaint since this product was launched in 2006. a warning statement will be added to the respective operator manuals specifying the need to perform the related maintenance task with special caution.
Acción
Roche Diagnostics will add a warning statement to the respective operator manuals, which will be available by December 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
Fujifilm has identified that in very rare cases, software versions v5.0, v5.1, v5.2, v6.0, v6.1 and v7.00 for specific workstations within the digital mammography system may possibly assign a duplicated id number to exposure images.Transmitting the image with the duplicated id number assigned to a pacs could possibly overwrite the image in an old study stored on the pacs. this would cause an unexpected image to appear when referring to the old study. the image and data of a new study does not have this issue, therefore, there is no effect on a diagnosis.Fujifilm has corrected the software that is the cause of such failure.
Acción
FUJIFILM has corrected the software that is the cause of such failure.
Actions to be taken by customer/user:
Make sure the latest images transmitted to PACS exists in the new study-where it should be. If the image with the duplicated ID number assigned is transmitted to PACS, you will fail to find it in a newly created study. (ie it is missing). This is because the image transmitted to PACS with that error overwrites an existing(older) study image and is stored in another(older) study.
If you have this error, please contact your local FUJIFILM office. Although the probability of the above error is very rare, systematically checking that the correct number of images per patient has been transferred to the PACS will make sure in case such errors occur.
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
Maquet cardiopulmonary has developed and validated new and revised cleaning and disinfection procedure for hcu 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all hcu 40 systems in the field.This update also includes the following actions:1. replacement of valves:existing valves will be replaced by successors with proven material compatibility with the new cleaning and disinfection procedure;2. replacement of flow sensors:in hcu 40 devices with serial number below 90440266 the mechanical flow sensor will also be replaced by its successor to ensure material compatibility with the new cleaning and disinfection procedure; and3. software update release 1.2.3.0:hcu 40 devices will be updated with the new software (release 1.2.3.0) including a new cleaning wizard guiding the user through the new cleaning and disinfection process step by step.
Acción
Actions to be taken by users:
1. The update on HCU 40 systems has to be performed by authorised Maquet service personnel according to the Update Instruction as soon as possible;
2. Fill out the supplied Acknowledgement Form and return it as soon as possible to your local Maquet representative;
3. Incorporate the new cleaning and disinfection procedures into operating processes, and conduct any necessary training;
4. Continue to monitor the hygiene (contamination levels) in accordance with internal practices; and
5. Immediately report any contamination findings to the local Maquet representative by filing a complaint.
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
Pentax medical has become aware of an error in the description of the instructions for use (ifu) for a specific model of pentax ultrasound video bronchoscope relating to the reprocessing of scopes. following the instructions in the erroneous ifu may result in ineffective reprocessing which may pose a risk of contamination and/or anaphylactic shock.
Acción
Pentax Medical is requesting customers ensure that all potential users in affected facilities are made aware of this recall action and are provided with the new Instructions For Use (IFU) supplied with 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
The vitek ms system could give, in specific conditions, an incorrect identification result if the tested species is not included in the vitek ms knowledge base (kb). when the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison. consequently, the system can give:1) no identification when the spectrum acquired does not match with any species pattern.2) a low discrimination identification when the spectrum acquired presents a high level of similarity with multiple specific species patterns present in the database.3) an incorrect single choice identification to the nearest pattern species when the spectrum acquired presents a high level of similarity with a specific species pattern present in the database.This is a system limitation with all maldi-tof databases which is currently not described in the user manual.
Acción
Biomerieux is requesting customers:
1. Distribute the supplied information to all appropriate personnel in your laboratory, retain a copy in your files, and forward the customer letter to all parties that may use this product, including others to whom you may have transferred our product;
2. Take this limitation into account;
3. Contact your local Customer Service in case of questions; and
4. Complete and return the supplied Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice
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
Zimmer biomet has discovered a raw material anomaly during an inspection of various trauma and extremity instruments (drill bits, screw taps and saw blades). an investigation by the supplier determined that four lots of raw material could have similar anomalies. the anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture. the affected units were distributed between the dates of march 2016 and may 2017.This issue may lead to extension of surgery < 30 minutes and/or the patient retains piece of fractured instrument leading to patient injury.This issue is not visually detectable in all cases. one injury has been reported internationally.
Acción
Zimmer Biomet is conducting a lot specific recall for various trauma and extremity instruments (drill bits, screw taps and saw blades).
Hospital Responsibilities:
1.Review this notification and ensure affected personnel are aware of the contents;
2.Assist the Zimmer Biomet sales representative quarantine all affected product;
3.The Zimmer Biomet sales representative will remove the affected product from your facility;
4.Complete the supplied Attachment 1 – Certificate of Acknowledgement;
a.Return a digital copy to RAQA.ANZ@zimmerbiomet.com
b.Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.
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
Abacus als is advising that immunocap allergen f205, herring, lot 999g5 contains the wrong allergen. this could cause erroneous test results, which may cause a delay in a proper diagnosis, however, the probability of a serious adverse health consequence or serious deterioration in state of health due to a delayed diagnosis is estimated to be negligible.
Acción
Actions to be taken by the customer/user:
1. Stop using the affected lots;
2. Discard any unused product;
3. Retest any samples that have been tested using the affected product; and
4. Fill in the Medical Device Recall return response form supplied with the customer letter and return to Abacus ALS.
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
Livanova has identified an issue of overconsumption following an electrostatic discharge (esd) during implant surgery or an mri scan.An electronic component in specific platinium devices has been found to be sensitive to esd, potentially generated during surgery. the discharge can trigger overconsumption of current, leading to reduced device longevity (5% loss per month). resetting the device will stop the overconsumption, but the residual longevity displayed by the programmer may be temporarily underestimated.Exposure to an mri's magnetic field can cause overconsumption, & the battery voltage will decrease to 2.80v. at this level, the remaining longevity is 25% of the initial longevity. to date, no permanent injury or death has occurred as a result of these issues. as of 16 june 2017, livanova has received 18 reports of overconsumption associated with esd exposure at implant, (0.19%), & 4 reports of overconsumption/premature device replacement attributed to mri (0.04%).
Acción
In order to mitigate the potential risks associated with both triggering events (ESD/MRI scan), LivaNova recommends physicians follow-up patients at the periodicity already stated in the implant manual, especially:
- Before the patient is discharged & at each subsequent follow-up, check the battery status & the occurrence of system warnings;
- It is recommended that a routine follow-up examination be done 1 month after discharge, & then every 3 months until the device nears the replacement date.
LivaNova does not recommend anticipating patient visits, provided that the IFU is followed.
If the warning “[A3] Technical issue” is displayed, this indicates that the device is affected by the overconsumption caused by an ESD at implant. Without delay, contact your LivaNova representative who will organise the reset of the device.
Complete and return the supplied Customer Reply Form ASAP.
For further information, please see https://www.tga.gov.au/alert/platinum-icds-and-crt-ds
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 investigation by in vitro technologies investigations of specific lots of human igm kit for use on spaplus have identified that the calibration stability has decreased in comparison to historical released kits. users will be able to identify when the calibration is no longer valid, as control values will fall outside of the provided acceptable limits.
Acción
The Binding Site recommends the following:
1. Batch sample analysis, when possible;
2. Recalibrate the assay when QC results have deviated outside of the specified range;
3. Contact In Vitro Technologies for any further guidance or additional kit requirements; and
4. Complete the acknowledgement form supplied with the customer letter, even if you do not have any of the affected product, and return it by email to QRA@invitro.com.au
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
Getinge has released revised disinfection procedure for heater unit hu 35. heater unit hu 35 is used during extracorporeal life support (ecls) in intensive care units to maintain the patient’s blood temperature via an oxygenator heat exchanger. there is no contact between the blood stream of the patient and the system water circulating through the heat exchanger. maquet cardiopulmonary as well as different national competent authorities have received isolated reports confirming the presence of bacterial contamination in the system water of hu 35 including mycobacterial counts. however, maquet cardiopulmonary has not received any reports that a mycobacterial infection or any other bacterial infection would have been caused by a heater unit hu 35.
Acción
The current published Instructions for Use chapter 6 “Cleaning and Disinfection” for HU 35 Heater Units will be replaced by a new Instructions for Use (IFU).
Action to be taken by the user:
1. Complete and return the enclosed Acknowledgement Form as soon as possible to your local Maquet representative;
2. Incorporate this revised procedure into your operating processes;
3. Conduct any training necessary for the revisions;
4. Continue to monitor the hygiene (contamination levels) in accordance with your internal practices;
5. Immediately report any contamination findings to your local Maquet representative by a complaint; and
6. Remind all users that the HU35 is not to be opened or filled in the operating room.
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
Steri-7 has identified a labelling defect where specific s7xtra ready to use has been incorrectly labelled as concentrate.
Acción
All S7XTRA Concentrate 5 litres bottles will need to be quarantined prior to return. Steri-7 will arrange pick up of the products in question and notify users of the next steps.
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 meridian has discovered that the sample preparation apparatus iv is susceptible to evaporation over the shelf life, causing low volume of the liquid reagent. post-market studies indicate that this component may not be stable through to the labelled expiration date due to this evaporation. internal testing by meridian has confirmed that the use of a low volume sample preparation apparatus component will result in an invalid test result.At this time, there is no indication that valid test results are impacted, and previously reported patient results require no additional action.
Acción
Meridian is requesting customers:
1. Identify existing inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015;
2. Contact Bioline directly, as necessary, for replacement product;
3. Complete and return the supplied Customer Response Form to Bioline; and
4. Upon receipt of replacement product, segregate and destroy remaining inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015.
All kit components should be discarded in accordance with local regulations.
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 of a product quality issue which could potentially affect the probp 2400 digital blood pressure devices manufactured by microlife and distributed by welch allyn. as a result of a defective electrical component in the battery charging circuit, when the probp 2400 is connected to the external power supply/battery charger, a potential over-voltage battery charging condition may occur. this potential defect resides with the device, not the battery.The over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic (abs) battery door and other adjacent plastic and foam device components.This issue may lead to patient and/or caregiver burns as result of skin contact with melted plastic and/or delays in treatment.
Acción
The affected devices within the Serial Numbers specified in the customer letter are being recalled and will be replaced with new devices at no cost to affected customers.