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.
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.
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
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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 JJE
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
Radioimmunoassay, dehydroepiandrosterone (free and sulfate) - Product Code JKC
Causa
The recall was initiated because beckman coulter has confirmed customer reports that dhea measurements using dhea ria (ref dsl-8900) kit lots identified may overstate actual dhea levels in patient samples.
Acción
Beckman Coulter sent an "URGENT: PRODUCT CORRECTION ACTION" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol,
17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was enclosed for customers to complete and return.
Contact the Beckman Coulter Technical Support Center at 1-800-854-3633 in the United States, or their local Beckman Coulter Representative for questions regarding this notification.
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 JGS
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
in vitro diagnostic device for quantitative determination of blood glucose level. - Product Code CGA
Causa
Incorrect configurations settings in software. as a result, certain error codes do not trigger appropriately. these error codes are: e01, e02 and e05 which are all related to the optronic performance of the analyzer. possible incorrect results.
Acción
Hemocue AB sent Customer Notification "Notice of Medical Device Correction on HemoCue Glucose 201 DM and HemoCue Hb 201 DM Analyzers" dated October 7, 2010, to customers notifying them of incorrect settings on error codes.
The corrective action consists of an update of the configuration settings on the the affected HemoCue Glucose 201 DM and Hb 201 DM analyzers that are in the field. The affected units in the field will be corrected in accordance with a rework procedure that has been established by HemoCue AB.
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
Real time nucleic acid amplification system - Product Code OOI
Causa
If the bar code is printed from the batch results screen, a wrong batch id may be printed, while the correct batch id is still assigned to the batch in the data repository of the mplc 2.0 software. this may result in sample mis identification. if printed from the ordering screens, the bar code is printed with the correct batch id.
Acción
The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 04, 2010 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to print batch ID barcode labels from the ordering or stage set up screens only; print Cooling Block barcode labels from the Post Elution Edit screen only; complete and return the attached UMDC Faxback Form for MagNA Pure LC 2.0 Instrument [UMDC 10-228] via fax to 1-877-551-7152 and file this correction notice for future reference. The firm plans to issue a software update in first quarter 2011.
If you have questions about the information contained in this UMDC, for Clinical customers, please contact Roche Molecular Diagnostics Technical Service at 1-800-526-1247; for Research customers, please contact Roche Applied Sciences Technical Service at 1-800-262-4911.
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.
Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the calcium assay.
internal investigations revealed the presence of precipitate in the r2 of the affected calcium reagent lots. the precipitate observed was classified as o-cresolphthalein complexone (o-cpc), a reactive component of the calcium r2.
the root cau.
Acción
The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference.
The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product.
Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.
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.
The firm has recieved complaints of imprecision and erroneous patient results for calcium on the cobas integra and cobas c 501 system using reagent lots 62601901 and 63020401.
Acción
The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference.
The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product.
Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.
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
Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
Causa
The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
Acción
The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration.
New bottles are opaque white in color.
Signs of deterioration include:
o Any color change to the bottle (yellow, orange or pink)
o Cracking
o Crazing (spider web cracking)
Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.
Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.
Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i
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
Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
Causa
The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
Acción
The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration.
New bottles are opaque white in color.
Signs of deterioration include:
o Any color change to the bottle (yellow, orange or pink)
o Cracking
o Crazing (spider web cracking)
Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.
Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.
Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i
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
Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
Causa
The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
Acción
The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration.
New bottles are opaque white in color.
Signs of deterioration include:
o Any color change to the bottle (yellow, orange or pink)
o Cracking
o Crazing (spider web cracking)
Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.
Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.
Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i
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
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Causa
The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
Acción
The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration.
New bottles are opaque white in color.
Signs of deterioration include:
o Any color change to the bottle (yellow, orange or pink)
o Cracking
o Crazing (spider web cracking)
Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.
Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.
Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i
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
Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
Causa
Beckman coulter has confirmed that non-reproducible falsely elevated test results may occur when using the access total bhcg assay. these elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range.
the role of preanalytical factors in laboratory testing has been described in a variety of published literature.
Acción
Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:.
" Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results.
" Follow the sample handling instructions provided in the Access Total ¿hCG Instruction for Use (IFU).
" Review the enclosed pre-analytical sample handling information bulletins:
1. The Role of Preanalytical Factors in Chemistry and Immunoassay Testing (P/N A34880A).
2. Sample Handling Makes a Difference (P/N A28226A).
" At the discretion of the laboratory director, any total ¿hCG result that is questioned due to lack of clinical correlation should be repeated.
NOTE: Due to the clinical utility of the Access Total ¿hCG assay as a biomarker of pregnancy, Beckman Coulter feels it is unnecessary to require a review of all previously obtained Access Total ¿hCG test results. The Access Total ¿hCG assay is intended as a marker for pregnancy at the time of testing. A discrepant or questionable result would have been brought to the attention of the laboratory. The pregnancy status of a patient at this point, post testing, would be known to the patient and the physician.
" Please share this information with your laboratory staff and your phlebotomy director and/or phlebotomy staff and retain this notification as part of your laboratory Quality System documentation.
" Complete and return the enclosed response form within ten days so they can be assured that this important notification has been received.
If you have any questions regarding this notification, please contact the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call
1-800-854-3633 in the United States and Canada. Outside 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
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.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
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.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
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.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
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.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
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.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
Glucose, oxidase, glucose - Product Code CGA
Causa
I-stat analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Acción
Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed.
Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action.
Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.