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
Investigation at abbott molecular identified that some of the 5ml reaction vessels (rv) contained in lots 56944001, 57026001, 57059001 and 57673001 may have insufficient rim. an rv with an insufficient rim may not be held securely in the 1ml subsystem carrier. this may cause the rv to be seated incorrectly in the carrier or drop through it. it is estimated that less than 1% of rvs within these lots may be defective. these lots have been in distribution since july 2012.
Acción
End users are advised to remove them from use any remaining RVs from lots 56944001, 57026001, 57059001, or 57673001 (original vendor lot 2198077). Replacement product will be coordinated on return of the receipt 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
Manufacturer confirms that the solid phase reagent in some of the advia centaur tni-ultra readypacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Acción
Siemens is providing work around instructions to users. Only one TNI-Ultra ReadyPack is to be used on a system at one time. Patient results produced by the assay are acceptable if they follow acceptable calibration with valid quality control results. Kit lots ending in 086 or higher do not require calibration of each ReadyPack, refer IFU for the calibration interval. This action has been closed-out on 11/04/2016.
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
Issue 1: loose drive support cap – if the loose drive support cap is pressed on, it could result in the unintended delivery of additional insulin.Issue 2: sensor graph timeout (only affects paradigm veo (mmt-554 and mmt-754)) – this issue could prevent the auto-resume of basaldelivery 2-hours after a low glucose suspend event, which can result in elevated blood glucose values.Issue 3: water damage– this issue may result in a pump alarm or cause the buttons to stop working.
Acción
Issue 1: Medtronic is asking consumers to regularly examine the pump especially after a shock or drop on a hard surface. If the drive support cap is sticking out, customers are asked to not press on this portion of the pump and to discontinue the use of the pump. Customers will need to manage their diabetes as per the back-up plan provided to them by their healthcare professional. Also, contact Medtronic 24 hour Helpline on 1800 777 808 (option 1).
Issue 2: Medtronic is providing work around instructions to prevent this issue from occurring.
Issue 3: Medtronic is asking customers to follow the user guide to prevent this issue from occurring.
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
Ortho clinical diagnostics has received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using vitros chemistry products phbr slides. an investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Acción
End users are requested to discard all lots of VITROS PHBR Slides. It is recommended that any concerns with previously reported patient results be discussed with the laboratory director and requesting physician.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There is the potential for vitros vapor adsorption cartridges sales unit cartons to incorrectly contain a particulate cartridge (part number j19612).
Acción
Ortho Clinical Diagnostics (OCD) is requesting end users to ensure that a VITROS Vapour Adsorption Cartridge is installed. If a Particulate Cartrtigde is installed it must be replaced immediately with the correct cartridge and reported to OCD Customer Technical Services. Results generated while a Particulate Cartridge was installed must be reviewed. Any concerns with previously reported patient results should be discussed with the laboratory director to determine the appropriate course of action.
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 has confirmed customer complaints of low patient sample recovery with tacr flex, lot fa3316. quality control materials have not exhibited low recovery of the same magnitude.
Acción
Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot FA3316. Laboratory Directors are also being advised to review patient tests to determine if follow-up testing is required.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The irish medicines board (imb) has been notified that freestyle mini® blood glucose meters and freestyle® blood glucose meters may give erroneously low blood glucose results and may produce out of range control solution results when using freestyle lite® and freestyle® blood glucose test strips.
Acción
Advice for End Users / Patients:
1. Follow the manufacturer’s instructions outlined in the attached FSN and contact Abbott Diabetes Care Customer Service on 1800 776633 for a replacement meter.
2. Ensure that you can continue to monitor your blood glucose appropriately. This should be done in consultation with your healthcare professional.
3. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). Symptoms may include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are
experiencing any of these symptoms or are not feeling well, contact your healthcare professional immediately.
Advice for Healthcare Professionals / Pharmacists / Distributors:
1. Follow the manufacturer’s instructions outlined in the attached FSN and contact Abbott Diabetes Care Customer Service on 1800 776633 for replacement meters.
2. Ensure that end users who dispose of affected blood glucose meters can continue to appropriately monitor their blood glucose.
3. Ensure that the appropriate personnel are made aware of this notice and the attached FSN. Please also pass this notice and the attached FSN on to any end user or organisation where the potentially affected blood glucose meters have been transferred.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Notas adicionales en la data
Causa
The irish medicines board (imb) has been notified that certain lots (lot numbers 1284962 and 1372611) of freestyle lite® blood glucose test strips may give erroneously low blood glucose results and may produce out of range control solution results when using freestyle® blood glucose meters, freestyle mini® blood glucose meters and the freestyle® meter built into the omnipod® system.
Acción
Advice for End Users / Patients:
1. Identify any test strips from the affected lots.
2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).
3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 008000 2255 232 or 1800 776633 for a replacement of the affected test strips.
4. Ensure that you can continue to appropriately monitor your blood glucose via test strips from a different lot number or by other means. This should be done in consultation with your healthcare professional.
• Pay special attention to signs and symptoms of high blood sugar (hyperglycemia).
• Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately. Advice for Healthcare Professionals / Pharmacists / Distributors:
1. Identify any test strips from the affected lots.
2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).
3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 1800 776633 for a replacement of the affected test strips.
4. Ensure that the appropriate personnel are made aware of this notice and the attached field safety notices. Please also pass this notice and the attached FSNs on to any end user or organisation where the potentially affected test strips have been transferred.
5. Ensure that end users who dispose of blood glucose test strips from the affected lots can continue to appropriately monitor their blood glucose.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding changes/updates made to instructions for use. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding the use of the device. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding changes/updates made to instructions for use. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding the use of the device:. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Electrode, ion specific, potassium - Product Code CEM
Causa
This recall was initiated because beckman coulter has confirmed that for user-defined chemistries (udrs), the polychrome correction is not automatically updated when wavelengths are modified.
Acción
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¿¿ DxC Clinical Systems
Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
-After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction.
-If the modified UDR requires calibration, recalibrate after rebooting.
- Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08.
In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them.
If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Electrode, ion specific, potassium - Product Code CEM
Causa
This recall was initiated because beckman coulter has confirmed that for user-defined chemistries (udrs), the polychrome correction is not automatically updated when wavelengths are modified.
Acción
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¿¿ DxC Clinical Systems
Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
-After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction.
-If the modified UDR requires calibration, recalibrate after rebooting.
- Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08.
In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them.
If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Electrode, ion specific, potassium - Product Code CEM
Causa
This recall was initiated because beckman coulter has confirmed that for user-defined chemistries (udrs), the polychrome correction is not automatically updated when wavelengths are modified.
Acción
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¿¿ DxC Clinical Systems
Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
-After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction.
-If the modified UDR requires calibration, recalibrate after rebooting.
- Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08.
In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them.
If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.