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.
Nanosphere has received several reports relating to an increased rate of processing errors during procedures performed on the processor sp caused by tips in tip holder assemblies for the following products and lots of extraction trays.
Acción
Nanosphere sent a Field Notification Letter dated October 10, 2013, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Instructions were included in the letter for customers to determine whether or not the extraction tray lots should be returned. If the extraction tray lots are to be returned, customers were to complete and return the attached form and replacement tip holder assemblies will be supplied at no cost. Customers could then dispose of the recalled unused tip holder assemblies. Customers with questions were instructed to contact their Nanosphere technical support representative.
For questions regarding this recall call 1-888-837-4436, ext 3.
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
Ferritin, antigen, antiserum, control - Product Code DBF
Causa
Ferritin analytical sensitivity and calibrator c realignment with kit lots ending in 22 and 23 used with the advia centaur ferritin assay on the advia centaur cp system.
Acción
Siemens issued an Urgent Field Safety Notice via e-mail to all US customers affected on October 9, 2012. This notice informs the customer of the Field Correction and the actions that need to be taken. The Urgent Field Safety Notice instructs customers that upon receipt of Calibrator C Lots ending in 25 and higher (Cal C lots CC25LA and higher and Cal C lots CC25HA and higher), discontinue use of the Calibrator C lots ending in 22 and 23 with the ADVIA Centaur Ferritin assay when used on the ADVIA Centaur CP system. A confirmation fax-back form is included to ensure that all customers worldwide
have been notified and have complied with the mandatory action.
Further questions please call (508) 668-5000
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
Supplement, culture media - Product Code JSK
Causa
Recalled product may not provide adequate recovery of legionella pneumophila when used as directed and may result in false negative identification of legionella pneumophila.
Acción
Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.
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
Device, general purpose, microbiology, diagnostic - Product Code LIB
Causa
A reagent within the test may return false negative results.
Acción
ThermoFisher sent a Medical Device Recall letter dated October 23, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative results for the affected product. Customers should review their inventory for the affected products and discard them. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed customers should contact those entities, advise them of the situation and provide them with a copy of this letter.
Customers with questions were instructed to contact their Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
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
Device, general purpose, microbiology, diagnostic - Product Code LIB
Causa
A reagent within the test may return false negative results.
Acción
ThermoFisher sent a Medical Device Recall letter dated October 23, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative results for the affected product. Customers should review their inventory for the affected products and discard them. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed customers should contact those entities, advise them of the situation and provide them with a copy of this letter.
Customers with questions were instructed to contact their Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
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.
Beckman coulter is recalling microstrep plus 1 and microstrep plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.
Acción
Beckman Coulter Inc. sent an Urgent Medical Device Recall letter dated Setember 10, 2015 to all customers who purchased the MICroSTREP plus 1 and MICroSTREP plus 2. The letter identified the affected products, problem and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the notice, are instructed to contact their Customer Support Representative:website: http://www.beckmancoulter.com or by phone: 1-800-677-7226 in the United States and Canada.
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.
Beckman coulter is recalling microstrep plus 1 and microstrep plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.
Acción
Beckman Coulter Inc. sent an Urgent Medical Device Recall letter dated Setember 10, 2015 to all customers who purchased the MICroSTREP plus 1 and MICroSTREP plus 2. The letter identified the affected products, problem and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the notice, are instructed to contact their Customer Support Representative:website: http://www.beckmancoulter.com or by phone: 1-800-677-7226 in the United States and Canada.
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
Research use only/microbiology - Product Code OTT
Causa
Focus diagnostics is recalling the anaplasma phagocytophilum ifa igm kit because of the potential increase in invalid results.
Acción
A recall letter dated 10/2/15 was sent to distributors who distributed the Anaplasma phagocytophilum IFA IgM (IF1450M) kit lots 26431 and 27011. The letter informs the customers that Focus Diagnostics received customer complaints of IF1450M with low reactivity, which may result in higher invalid rate. The letter also provides the customers with Focus Diagnostics' recommendations and actions to be taken by the distributors. Customers with questions or require additional information are instructed to contact Focus Diagnostics' Technical Services department at (562) 240-6550 from 7am to 5pm (PST) or send an email to DxTS@focusdx.com.
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
Ige, antigen, antiserum, control - Product Code DGC
Causa
According to the firm, the ige calibrator series ie2492 (lot 387-392ie) value assignment has now been aligned to the 3rd international standard for human serum ige 11/234.
turbidimetric (non-ifcc cal.) quality control targets and ranges now apply. the calibrator value sheet is to be updated with the new values.
Acción
The firm plans on contacting each consignee about the recall.
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, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
Causa
Ca 19-9 assay on the advia centaur cp does not meet the correlation to the ca 19-9 assay on the advia centaur/xp/xpt
systems as stated in the instructions for use.
Acción
Siemens Healthcare issued Urgent Medical Device Correction (UMDC) to Siemens Healthcare Diagnostics customers in the United States on October 19, 2016 to be delivered to customers on October 20, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 18, 2016. The notice informs the customer of the potential to observe a bias between CA 19-9 results generated on the ADVIA Centaur CP and the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Customers may continue
to use the ADVIA Centaur CA 19-9 assay to report patient results on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT and ADVIA Centaur CP systems. Customers should not use the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems interchangeably with the ADVIA Centaur CP when generating CA 19-9 results.
For customers using the ADVIA Centaur CP and ADVIA Centaur/XP/XPT for CA 19-9 interchangeably, a look back of patient results over the previous three months is recommended.
A Field Correction Effectiveness Check is to be completed, signed and returned Siemens.
Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative.
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, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
Causa
Ca 19-9 assay on the advia centaur cp does not meet the correlation to the ca 19-9 assay on the advia centaur/xp/xpt
systems as stated in the instructions for use.
Acción
Siemens Healthcare issued Urgent Medical Device Correction (UMDC) to Siemens Healthcare Diagnostics customers in the United States on October 19, 2016 to be delivered to customers on October 20, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 18, 2016. The notice informs the customer of the potential to observe a bias between CA 19-9 results generated on the ADVIA Centaur CP and the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Customers may continue
to use the ADVIA Centaur CA 19-9 assay to report patient results on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT and ADVIA Centaur CP systems. Customers should not use the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems interchangeably with the ADVIA Centaur CP when generating CA 19-9 results.
For customers using the ADVIA Centaur CP and ADVIA Centaur/XP/XPT for CA 19-9 interchangeably, a look back of patient results over the previous three months is recommended.
A Field Correction Effectiveness Check is to be completed, signed and returned Siemens.
Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative.
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
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Causa
Customer complaints identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
Acción
Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.
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
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Causa
Customer complaints identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
Acción
Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.
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
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Causa
Customer complaints identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
Acción
Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.
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
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Causa
Customer complaints identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
Acción
Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.
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
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Causa
Customer complaints identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
Acción
Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.
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
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Causa
Customer complaints identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
Acción
Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.
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
Plates and equipment, radial immunodiffusion - Product Code JZQ
Causa
If a control ring is marked after reading, the software will not flag results that are out of the specified qc range.
Acción
On 10/2012 notification letter was sent to customers requesting they take the following actions:
1. If have not already installed software version Vl.0.3 then please continue to work with version V1.0.2 until the above issues are resolved.
2. If have already installed software version V1.0.3, when processing results always mark the controlprior to reading the ring.
3. If are uncertain about the validity of any assays you have performed using software version Vl.0.3 please review the controlresults obtained and compare them to the specified control range for the RID assay and;
" If the control results are acceptable then your assay is valid and results will be unaffected.
" If the control results are not acceptable your assay should be considered invalid and your patient results should be reviewed and repeated as appropriate.
On 02/2013 a second notification was sent in which customers were informed the new software was released.
Customers were asked to take the following actions;
1. Upon receipt install the new software and uninstall the previou version
2. Install following the onscreen instructions. The installation process has not changed from previous versions. The instruction guide received with the RID Plate reader is still the current version.
3. After receipt of the new software disc complete and return the Eback form to The Binding Site.
For further assistance contact Technical Services at The Binding Site via the email address: technicalservices@bindingsite.co.uk.
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
Lambda, antigen, antiserum, control - Product Code DEH
Causa
A change in the calibration curve causing an increase in false prozone flags.
Acción
Binding Site sent an Important Notice dated October 28, 2016, to all affected customers. .
Binding Site requests the following:
- Immediately quarantine and dispose of any LK018.S lot 400012 / LK018.10S lot 400257 kits held in your organisation;
- Remove any affected lots from the SPAPLUS instrument;
- Contact Binding Site representative to request replacement kits;
- Return completed E-back form to your local Binding Site representative.
For questions regarding this recall call 858-453-9177.
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.
Recall letters dated 10/28/03 were issued via regular mail instructing the customer to examine the kits to determine whether they contain the CMV IgG SPRS and destroy them if found.
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
Over heating of memory board.
Acción
Consignees were notified by letter on September 17, 2004.
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
Hepatitis A Test (Antibody And Igm Antibody) - Product Code LOL
Causa
Abbott identified through investigational studies that imx havab controls lot 18220q100 is generating negative control values outside the upper range specified in the imx havab package insert.
Acción
Device recall letters were dated 10/27/2004. Letter was mail to customers asking to destroy and discontinue use of device. On hand inventory information was requested to be forward to Abbott at 1-800-777-0051 (U.S. only).
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.
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. - Product Code GNC
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Antiserum, Positive And Negative Febrile Antigen Control Serum - Product Code GSN
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.