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
R&r; healthcare identified that the hercules patient lifter, the spreader bar (which holds the sling) is secured to the lifter arm by a lock tighten dome nut. there has been one report of this dome nut becoming loose causing the spreader to detach from the lifter arm, resulting in a client fall.
Acción
R & R Healthcare is advising distributors to inspect stock and ensure the dome nut is tight. A repair kit will be provided for all lifts to be inspected.
Users are advised check that the dome nut is tight, and the spreader bar is secured to the lifter arm. The supplier of the lift will be installing an additional locking pin to the lifter.
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 discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. two reports were received with the product/label discrepancy. in one report, the labelling of the implant box outer label stated size 2 rm/ll, and the labelling of the implant sticker (patient label) located inside the outer box state size 7 rm/ll. the correct implant size 2 rm/ll was inside the box. the patient label was incorrect in this report. the second report described that a size 2 implant was in a box labelled as a size 7 implant.
Acción
Stryker is advising users to quarantine affected stock immediately. Customers should contact their Stryker representative to arrange for return of affected 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.
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Causa
Medtronic is recalling the prior configuration of synchromed ii implantable drug infusion pumps, as a new configuration is available with an enhanced motor design. this recall action only relates to unimplanted devices.Medtronic has received regulatory approval for a design change to the synchromed ii implantable drug infusion pump. this design change of the motor decreases the potential for intermittent or permanent motor stall which can cause loss of therapy. all synchromed ii pumps are now being manufactured and distributed with this change.
Acción
Medtronic will liaise with hospitals to review their inventory to locate affected pumps. Medtronic will arrange return and replacement of affected pumps.
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
Boston scientific (bsc) is initiating a removal of certain malecot nephrostomy catheters due to reports of some catheters breaking at the mid-shaft bond during use. the bond is located where the renal end of the malecot catheter is bonded to the catheter shaft. bsc has received seventeen (17) complaints for this issue since december 1, 2013. there have been no injuries reported as a result of this issue,.
Acción
Boston Scientific is advising users to inspect stock and quarantine any remaining units of the affected product. Stock can be returned to Boston Scientific for credit.
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 base of the architect cuvette segment may become detached under specific conditions. when a segment base is detached, cuvettes may be seated lower than the designed height. this may result in inadequate dispense into specific cuvettes due to the sample probe being unable to makeefficient contact with the cuvette bottom.Reasons for the bottom of the cuvette segment to detach are• excessive force applied during manual cleaning of cuvettes or cuvette wash tower crashes• lack of sufficient glue during cuvette segment manufacturing (c4000 and c8000 only)if a segment is detached, there is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the instrument. falsely depressed results may or may not be accompanied by a result flag.
Acción
Impacted patient results may be accompanied by “<” or “LOW” result flags, indicating that the result is below the linear range or the defined normal range of the assay, respectively. See ARCHITECT System Operations Manual Section 5: Operating Instructions for more information on patient result flags.
Abbott is providing users with new instructions to avoid damaging the cuvette segments.
A review of previously generated patient results is at the discretion of the Laboratory Manager,
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.
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Causa
The manufacturer, the binding site, have identified that the barcode label for the affected lot is incorrect and will not be recognised by the spaplus instrument. this lot number cannot be used to complete the weekly wash. there is no clinical impact associated with this issue.
Acción
In Vitro Technologies is advising users to quarantine and dispose of any remaining units of the affected 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
Cook medical has become aware that certain transseptal needles may be the incorrect length, and is initiating a recall of lot 8181945. potential adverse events may occur by using the nonconforming products, including being unable to perform the transseptal puncture. this could necessitate replacing the device or rescheduling the procedure. in addition, use of the nonconforming products could make the puncture less controlled, which could potentially lead to injury of the heart.
Acción
Cook Medical is advising customers to quarantine affected stock from their inventory for return to the sponsor for a product credit as per the instructions given 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
Interpath have become aware of an issue regarding inconsistent volumes of citrate present in a certain batch of the vacuette minicollect complete 1ml sodium citrate 3.2% tubes which may affect patient results.
Acción
Interpath is advising customers to inspect stock and quarantine all tubes of batch A17083KP. Customers should then complete the reply form provided with the Customer Letter so Interpath may arrange for stock to be recovered and replacement stock issued.
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 has been made aware of an issue with the artis systems with artis tables. the artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap right is used to secure the bolt. in the case of a missing or wrongly installed snap ring the bolt could slide out of its base, and the table top carriage will slide to the floor.
Acción
Siemens Healthcare will be in contact with affected customers to arrange for a service to ensure the snap ring has been installed correctly.
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
On tuesday, november 28, 2017, the therapeutics goods administration (tga) notified boston scientific of tga’s decision to remove two transvaginally implanted boston scientific mesh products from the australian register of therapeutic goods (artg), effective january 4, 2018.The tga believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices. further information can be found on the tga website.As a result boston scientific is recalling all uphold lite with capio slim and solyx single incision sling system products from the australian market.No other boston scientific devices are affected by this recall.
Acción
Boston Scientific is advising hospitals to immediately discontinue use of and segregate affected product. The devices should be stored in a secure location for return to Boston Scientific. Instructions for product return are provided on the Customer Letter issued 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
Boston scientific has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer’s pacing lead system, but boston scientific has determined it to be more likely for affected boston scientific pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
Acción
A software upgrade is being developed for distribution in early 2018. Until this is available to automatically resolve MV sensor signal oversensing, Boston Scientific recommends managing the risk for patients implanted with affected systems as follows:
·Subject to the the guidance supplied to customers, turn the MV sensor to “OFF”
·If transient, abrupt changes or any out-of-range RA/RV pacing impedance measurements are observed, contact Boston Scientific Technical Services to explore all non-invasive programming options prior to surgical intervention
·For patients with the MV sensor enabled, periodically re-assess for pacemaker dependence
Doctors are encouraged to
·Enroll and follow patients using the LATITUDE NXT Remote Patient Management System
·Provide the supplied patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is 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
Boston scientific has been made aware of unintended asynchronous biventricular (biv) pacing behavior when tracking elevated atrial intrinsic rhythms in certain boston scientific cardiac resynchronization therapy (crt) pacemakers (crt-ps) and defibrillators (crt-ds). repeated detection of this unintended asynchronous biv pacing behavior may result in the implanted device reverting to a permanent safety mode (safety core™) status thus requiring early replacement.
Acción
Doctors should review programming records of patients implanted with the CRT devices described in Appendix B of the letter. If the LV Offset parameter is programmed to a Positive value, follow the supplied instructions to determine the need for changing the pacemaker settings.
Boston encourages doctors to provide the patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is available.
Maintain awareness of this issue until the software fix becomes available, and display this letter in a prominent place.
If a positive LV Offset is desired for a newly implanted Boston Scientific CRT device, consider the patient’s individual medical needs and either program the A-Blank after V-Pace value greater than the positive LV Offset value, or disable Tracking Preference by programming it to a value of “OFF”.
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
Merit medical systems, inc. is conducting a recall of specific lots of prelude snap splittable sheath introducers due to an intermittent failure of the splittable hub. merit medical has received complaints indicating that the wings on certain lots of the prelude snap have broken off the sheath hub during splitting. this will likely result in a minor delay in procedure. although rare, this could also result in a pacing lead/catheter displacement, air embolus, or minor hemorrhage. merit has received no reports of patient harm or injury as a result of this issue.
Acción
Users are advised to check inventory for affected devices and discontinue their use. Affected stock should be returned to Merit 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
Radiometer previously informed users that they had received reports of occurrences of the tcm5 causing interferences on ecg and eeg monitors (tga ref: rc-2017-rn-01327-1).There is a possibility that tcm5 flex/basic can cause interferences to ecg or eeg measurements, however, only when applied on the same patient.The problem may also concern other highly sensitive devices including: ecg, eeg, emg, mmg, eog, gsr, meg, icg. for this reason the instructions for use include the following warning:warning – risk of interferenceother instruments sensitive to electromagnetic interference may be affected by the tc measurement. if this is the case, contact authorised service personnel.The described effect may potentially lead to incorrect measurement results by 3rd party devices, such as an ecg monitor due to interference by the tcm5 flex / basic monitor. these incorrect measurement results may potentially lead to incorrect treatment or management of the patient.
Acción
Radiometer is advising users to choose one of the options below in order to avoid the issue from occurring.
Option 1: Connect the TCM5 monitoring system to a grounded Ethernet network using a shielded Ethernet cable. Please contact Radiometer if this option is selected. Radiometer will assist in verifying that the Ethernet network is indeed grounded and in selecting types of Ethernet cables verified by Radiometer.
Option 2: Disconnect the TCM5 monitoring from the mains supply and run it on battery only. Users can use the monitor for up to 4 hours with a fully charged battery.
Option 3: If alternative monitoring system is available consider to use that while waiting for the final solution from Radiometer.
In case none of the above options are feasible Radiometer requests users to refrain from combining the TCM5 FLEX/BASIC measurement with an EEG or ECG measurement.
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 has recently become aware of the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.There have been no reported injuries as a result of this issue.
Acción
GE Healthcare is advising hospitals to discontinue use of the affected Rotating IV poles and remove from service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact customers to arrange for the removal & replacement of a new IV pole.
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 result of internal investigations, beckman coulter has determined that certain duraclone b27 reagent kits have a defect that may generate false negative results in some samples. this defect is most likely to affect samples with mfi values between 10 to 19 when tested on navios/cytomics fc 500 cytometers and channel values between 517 to 602 when tested on bd facscalibur/ bc facscan cytometers.There has been no report of death or injury related to this defect.
Acción
Beckman Coulter is advising users to run tests of lot numbers 050917, 070417_11, 090517, 120617_02, 170417_09, 170417_11, 170417_11, 190617 and 240717 with the new determinant and indeterminant zone values provided with the Customer Letter. Other affected lot numbers should be disposed of in an appropriate manner. Affected customers may contact their local Beckman Coulter representative for replacement product.
Beckman Coulter recommends if required, redetermination of those results obtained for the above specified 8 lot numbers using the new determinant values outlined in the Customer Letter.
For all lot numbers, Beckman Coulter recommend samples previously reported as ‘negative’ to be verified using alternate methods such as PCR if considered necessary.
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 is issuing a notification following reports that the signia power handle may shut down unexpectedly during use. the signia power handle battery management system may incorrectly report the battery relative state of charge, which can result in a display showing more battery life than is available. in some cases, the power handle may have insufficient energy to complete the intended operation. use of the affected product may result in the need to use the manual retraction tool to remove the device from tissue.No patient injury or impairment has been reported for this issue.
Acción
Medtronic is advising users that a software upgrade will be implemented as a permanent correction.
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 has confirmed through internal investigation that certain immulite/immulite 1000/immulite 2000/immulite 2000 xpi assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results of the affected assays. the instructions for use (ifu) currently do not list biotin as a potential interferant.Concentrations of biotin above the determined concentration can potentially result in interference greater than 10%, leading to either falsely elevated or falsely depressed results. cea, folic acid, om-ma (ca125) and vitamin b12 exhibited falsely elevated results with the determined biotin concentrations.3gallergy specific ige, anti hbc, br-ma (ca15-3), ck-mb, epo, gastrin and thyroglobulin exhibited falsely depressed results with determined biotin concentrations.
Acción
Siemens is providing users with updated information regarding biotin interference and updating the Instructions for Use (IFU).
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
Stryker has initiated a lot specific product recall on certain lots of guider 7f and 8f product which may be at risk of degrading within their shelf-life period. the root cause of the issue is exposure of components to uv light while in storage between 2014 and october 2017.There have been no reports of injuries associated with this issue.
Acción
Stryker is advising users to inspect stock an quarantine any remaining units of the affected product. Affected stock can be returned to Stryker and replaced with unaffected 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
Philips has discovered that the nbp measurement of x3 intermittently displays only mean values instead of the diastolic and systolic blood pressure values. furthermore, occasionally the monitor shows the ‘check touch input” message, indicating that the touchscreen controls may not function.
Acción
Philips will distribute a software update for the affected devices and replace the display assembly. Philips has provided a workaround until the corrections are implemented.
Users should consider using an alternative monitor in situations where the touchscreen controls are needed when using the X3 in standalone mode.
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
Omsc has received a small number of adverse event reports globally for the urf-v2 associated with damage to the bending section. to date, no adverse events have been reported to olympus in australia for the urf-v2 and no adverse events reported globally for the urf-p6. further to olympus’ safety alert issued in december 2016 (rc-2016-rn-01653-1), the manufacturer has modified the design of the bending section of the urf-v2 and urf-p6 to address any deficiencies that may have attributed to the adverse events reported globally.
Acción
Olympus is advising hospitals to identify affected devices from their inventory. When replacement URF-V2 and URV-P6 devices are available, an Olympus Customer Operations Specialist will contact users to exchange devices at affected facilities. In the interim, users may refer to the IFU and Safety Alert issued by Olympus for the correct inspection and use of the 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
There is a potential for the display processor to experience an unexpected failure. if this failure occurs, the device screen will temporarily go blank and will then display an error code “ec01 xx”. the blank display results in loss of monitored data being displayed to the user. there have been no injuries reported as a result of this issue.
Acción
GE Healthcare is advising users that the system can continue to be used. In the event this issue occurs, an audible alarm will sound. Mechanical ventilation will continue at previous settings. A device restart is required to clear the alarm condition. Consider using appropriate alternative means of ventilation such as a self-inflating bag or another ventilator to prevent patient injury while restarting the device.
GE Healthcare will be implementing a software upgrade as a permanent correction.
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 hematology has identified the following issue with the cell-dyn emerald 22 analyzer application software v3.0.0 when the iuo (information use only) reporting option is disabled.For the printout of the levey-jennings (l-j) graphs, the wbc subpopulation differential labels do not match the l-j graphs. the labels are displayed in the following order: lym%, mon%, neu%, eos% and bas%, instead of neu%, lym%, mon%, eos%, and bas%. the graphs themselves are in the order of neu%, lym%, mon%, eos%, and bas%. all printed qc raw data results are correct.
Acción
Abbott is advising users to stop using the printouts of the Levey-Jennings (L-J) graphs and use the QC results or the on-screen display. A software upgrade will be performed as a permanent correction.
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 falsely elevated results may be obtained when using the architect dhea-s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation. although falsely elevated results have only been observed with samples from infants up to 60 days old, the expected values representative data for children up to 10 years old provided in the architect dhea-s reagent insert should not be used as these reference ranges are being reviewed as part of the investigation.All in-date lots of current reagent inventory are impacted.
Acción
Abbot is advising users to immediately discontinue use of the ARCHITECT DHEA-S assay with samples from infants up to 60 days old and to immediately discontinue use of the ARCHITECT DHEA-S reagent insert Expected Values representative data for children up to 10 years old.
Users are advised to review this letter with the Medical Director and follow laboratory protocol regarding the need for reviewing previously reported patient results.