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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
Acción
Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
For questions regarding this recall call 1-800-328-2910.
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.
Some devices may be contaminated on the back side of the device with glue in the blood application area.
Acción
The firm, Perkin Elmer, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated September 5, 2013 via email to its consignees. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately notify all submitting facilities and personnel that have received the PerkinElmer 226 Sample Collection Device of the potential glue contamination and to distribute the enclosed record of actions form to all submitting facilities/personnel and encourage them to perform the inspection activities as listed in the letter; and complete and return the enclosed Recall Response Form return it to PerkinElmer Health Sciences via fax to: 864-299-8797 or email to: Rick.Haines@perkinelmer.com.
Please contact PerkinElmer Health Sciences Greenville facility Quality Manager for further information 864-299-8787 (ext 104).
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
Sterilizer, chemical - Product Code MLR
Causa
Advanced sterilization products (asp) is recalling the three lots (13f049, 13f050, 13f051) sterrad 100nx cassettes because asp has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
Acción
Advanced Sterilization Products (ASP) sent an Urgent Medical Device Recall letter on September 18, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to examine their inventory and return all affected cassettes using the enclosed prepaid UPS return lave to Stericycle. Customers were asked to count their inventory and record the data on the enclosed Business Reply Card and Packing Slip. Customers were asked to provide the notice to anyone in their facility that needs to be informed. Customers were also asked to maintain a copy of the notice with the affected product. Customers with questions or suspected problems were instructed to contact Stericycle directly at 1-877-257-7119.
For questions regarding this recall call 949-453-6400.
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
Endovascular graft, aortic aneurysm treatment system - Product Code MIH
Causa
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by ifu.
Acción
A Medical Device Information letter was sent to all affected customers on September 19, 2012. Additionally, all Medtronic Field Representatives were notified of the issue via a Field Memo
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
System, blood culturing - Product Code MDB
Causa
An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
Acción
BD sent an Urgent Product Recall letter dated September 2013 to customers identified as microbiology lab managers. The letter identified the affected product, problem and actions to be taken. The letter advised that referenced lot numbers may contain an overlabel barcode that may begin to lift, exposing the original incorrect barcode pictured in the notification. Customers were instructed to complete the attached form and fax to Regulatory Compliance 410-316-4258. For further assistance regarding replacements contact BD Customer Service Department at 1-800-675-0908 and all other inquiries contact BD Technical Services Department at 1-800-638-8663.
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
Sterilizer Chemical - Product Code MLR
Causa
Advanced sterilization products (asp) is recalling the sterrad 200 sterilization system because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Acción
A customer notification letter was sent on September 18, 2013, to all customers who received the STERRAD 200 Sterilization System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to indicate if they have received a STERRAD 200 System and to report any complaints or suspected problems to Advanced Sterilization Products (ASP) Professional Services directly at (888) 783-7723 and select option #2.
An alternate design for the oil mist filter is being developed and qualification of new vacuum pump oil is in process. This action is to modify the PM interval to service the filter and oil more frequently. This will serve as an immediate/interim solution to reduce incidence of odor/smell complaints until the new oil mist filter design and vacuum pump oil are released.
A Customer Letter will be sent to all STERRAD 200 customers to notify them of the issue and the corrective actions we are taking to resolve this issue.
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
Azo dye, calcium - Product Code CJY
Causa
Calcium arsenazo reagent, reference cala-0250, is recalled due to complaint of plasma specimens report high results than serum.
Acción
ELITech Group of Bothell, WA sent an Urgent: Product Recall Notice dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions to be taken:
" Laboratories must not use plasma for the determination of total calcium when using this product. The product can still be used to determine total calcium with serum sample.
" ELITech Clinical Systems SAS has revised the package insert and kit box label for the CALCIUM ARSENAZO reagent reference CALA-0250. All mentions of the use of the plasma will be removed from the documentation. If you have inventory of CALCIUM ARSENAZO, reference CALA- 0250. All lots. in your laboratory, please discard the insert that you have and replace it with the insert enclosed with this notice.
" If you have transferred any of this product to another location, please forward a copy this bulletin to that location.
" All users receive CALCIUM ARSENAZO, CALA-0250, from distributors. To be certain everyone who is possibly affected by this change is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached receipt confirmation to Technical Support by fax (401-642-9003) within 48 hours of receipt.
We apologize for the inconvenience that this situation can cause in your laboratories; we remain at your disposal for further information. If you have any questions, please contact Technical Support at 1-855-ELITECH (855-354-324)
We thank you for your cooperation and the attention which you will give to this bulletin.