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
Ventilator, continuous, facility use - Product Code CBK
Causa
Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
Acción
Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered.
Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request.
Should you have any questions or require additional information, please call (714) 427-5811 extension 344.
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 recall was initiated because newport medical has confirmed a limited number of power cords recently received from their supplier, glob-tek, have a slightly oversized plug connector which prevents the
cord from locking into place. these cords are fully functional as supplied. however, the cord can be easily disconnected. if the cord is disconnected, the ht70 will alert the user with a power di.
Acción
Newport Medical sent an PRODUCT NOTICE LETTER, dated September 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer.
Customers were instructed to discard the original cord and only use the replacement cord to avoid unintentional disconnection of the power cord.
Each affected Customer was sent a replacement cord.
Customers with any questions regarding the Product Notice were instructed to contact the Technical Support Department at (800) 451-3111.
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
Camera, surgical and accessories - Product Code KQM
Causa
Mako surgical corporation recalled one infra-red camera mako pn 204854 which was a component of their rio robotic arm interactive orthopedic system with ssn p7-03127, on november 22, 2010. this component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. the recall was initiated after the camera manufacture, ndi, waterloo, on.
Acción
The firm, MAKO, sent a "RECALL NOTICE" letter dated November 22, 2010, to its customer. The letter described the product, problem and action to be taken. The customer was instructed to complete and return the attached Acknowledgement Form to their MAKOplasty Specialist (MPS) via mail to: MAKO Surgical Corp., Attn: Jim Pomeroy, 2555 Davie Road, Fort Lauderdale, FL 33317. The letter stated that "It is important that the camera be replaced immediately, and MAKO is currently addressing the situation with the camera manufacturer." In addition, MAKO will replace the camera with a camera that is not affected by the recall and verify the customers system to meet the functional specifications.
If you have any questions or concerns, please contact your MPS or Sr. Director of Quality Assurance at 954-927-2044 ext 604, and /or Sr. Director, Customer Support at 954-927-2044 ext. 442.
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, esophageal pacing - Product Code LPA
Causa
Cardiocommand, inc. is recalling their tapscope 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ecg.
Acción
On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall. The letter identified the affected product and reason for the recall. Users were asked to discontinue use and return the affected product to the firm. If all product was already used, then this should be indicated on the form provided. The firm will send replacement product in quantities equal to the returned product. The attached form should be completed and returned via fax. Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Service.
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
UniCel DxH 800 Analyzer - Product Code GKZ
Causa
Sharp edges on drawer slides within the dxh800 floor stand (cabinet) may expose operators to physical injury while replacing reagents and waste containers.
impact:
there is potential for exposure to blood borne pathogens such as hiv, hbv, and hcv.
Acción
Beckman Coulter sent an Urgent Product Corrective Action letter dated October 20, 2010, with a PCA Response Form (via US PostalService) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. This letter informed the customers about the problems identified and provided an action/resolution to this issue.
Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.
Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter 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
Counter, differential cell - Product Code GKZ
Causa
Body fluids results may be incorrectly interpreted by the laboratory information system (lis).
body fluid results ~ 1,000 celis/ul are reported using the us numeric separators to demark thousandths places (comma, ",") and partial units (decimal, "."). an lis that uses non-us formats could interpret the comma as a partial units separator, which could lead to reporting erroneously low body fluid r.
Acción
The firm, Beckman Coulter, issued an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following:
1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation.
2)Do not use pre-diluted samples for RETIC counts. The instrument is validated for pre-diluted CBC's only, as indicated in the Instructions for Use (IFU).
3)Verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and that the Body Fluid results are properly validated at the LIS.
4) Use the lip on the reagent drawer to move the drawer as shown. Avoid touching the drawer slides while replacing containers. Clean all spills promptly to reduce the risk of exposure to blood borne pathogens.
5)Complete and return the enclosed PRODUCT CORRECTIVE RESPONSE FORM within 10 days, share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.
Beckman Coulter will make corrections in future version software.
Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter 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
Counter, differential cell - Product Code GKZ
Causa
Retic results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the retic test panel. beckman coulter has validated pre-diluted specimen processing in cbc panels. retic test panel using pre-diluted samples has not been validated.
impact:
the reticulocyte value is an indicator for assessing red cell production. erroneous results could impact c.
Acción
The firm, Beckman Coulter, issued an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following:
1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation.
2)Do not use pre-diluted samples for RETIC counts. The instrument is validated for pre-diluted CBC's only, as indicated in the Instructions for Use (IFU).
3)Verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and that the Body Fluid results are properly validated at the LIS.
4) Use the lip on the reagent drawer to move the drawer as shown. Avoid touching the drawer slides while replacing containers. Clean all spills promptly to reduce the risk of exposure to blood borne pathogens.
5)Complete and return the enclosed PRODUCT CORRECTIVE RESPONSE FORM within 10 days, share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.
Beckman Coulter will make corrections in future version software.
Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter 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
Counter, differential cell - Product Code GKZ
Causa
For panels containing cbc: the rbc and hct are improperly corrected and not flagged when there is a wbc pump failure and the wbc ~ 140x103/ul.
for body fluid panels:
the rbc is improperly corrected and not flagged when there is a wbc pump failure.
impact:
erroneous rbc and/or hct could affect the interpretation and management of patients at risk with various types of anemias.
Acción
The recall communication was initiated on 10/20/2010, with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with PCA Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter informs the customers about the problems identified and provides an action/resolution to this issue.
When a WBC Pump Failure occurs, the WBC or TNC results will be flagged with 'R' and the WBC Pump Failure System message. The RBC and/or HCT results associated with these affected analyses also require review. This will be corrected in a future version of software.
Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation.
Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter 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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
When rt plans are exported from xio and rt structure sets and images are exported from monaco, the dicom iso-center coordinates may not be accurate.
Acción
Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice.
For questions regarding this recall call 408-830-8000.
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.
When a dialog box is displayed and the dose status is changed to "dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). then if cancel is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t.
Acción
The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 6, 2010 to its affected customers. The notice describes the product, problem and actions to be taken (workaround). The customers were instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue.
The notice also states that this problem has existed since XiO Release 4.2.0 and will be resolved in XiO Release 4.70.00. Elekta will notify the sites when this solution is available.
If you have any questions, please call 314-993-0003 or Toll Free: 800-878-4267.
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.
Xio: when the beam template is recalled, xio prematurely initiates a dose calculation, re-snaps the mlc or port to the structure of the current patient , but then fails to re-calculate dose for the new mlc or port position. if no subsequent change is made to force a dose recalculation, xio will display the dose from the original mlc/port shape dose instead of the dose from the re-snapped mlc/port.
Acción
The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 14, 2010 to its affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to distribute this notice to any all users of CMS software at their organization who are potentially affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety Notice.
The notice also states that this problem has existed since the XiO Release 4.3.0 and is resolved in the XiO release 4.26.00. Elekta will notify the customers when this solution is available.
If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
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
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
Catheter, infusion - Product Code JCY
Causa
On 09/13/2010 conmed linvatec, largo, fl initiated a recall on 24k100 arthroscopy outflow/suction tube set used with the conmed linvatec 24k pump. the 24k100 arthroscopy outflow/suction tubing set lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.
Acción
Linvatec Corp. dba ConMed Linvatec sent an Urgent Medical Device Recall Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to immediately check their facility's inventory for the affected product. If they had any of the product they were instructed not to use and segregate the product and return for credit.
Return the affected products and the completed REPLY FORM to their local ConMed Linvatec office.
If the product was transferred to another facility, customers were instructed to complete the REPLY FORM documenting the transfer of the product and mail or fax the REPLY FORM to their local ConMed Linvatec office at 727-319-5701.
If the customers do not have the affected product they should complete the REPLY FORM and mail in the enclosed envelope or fax to 727-319-5701.
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
Counter, differential cell - Product Code GKZ
Causa
There is a possibility that a specimen could be diluted if a user requests diluent dispense while specimens are being automatically processed in cassette presentation. the dilution may cause erroneous results.
impact:
erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu.
Acción
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with PCA Response Form (via US Postal Service for US customers) dated October 20, 2010, to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter describes the product, problem and the following actions to be taken. The customers were instructed to remove all cassettes from the mix station prior to initiating the Diluent Dispense function to prevent the likelihood of a specimen being diluted; do not use pre-diluted samples for RETIC counts; verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and the Body Fluid results are properly validated at the LIS. This will be corrected in a future version; use the lip on the reagent drawer as shown in the picture above; avoid touching the drawer slides while replacing containers; clean all spills promptly to reduce the risk of exposure to blood borne pathogens; complete and return enclosed PRODUCT CORRECTIVE ACTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7503/7504; mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015 or email to: Regulatory.Notifications@beckmancoulter.com, and share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation.
If you have any questions regarding this PCA, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter 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
Counter, differential cell - Product Code GKZ
Causa
There is a possibility that a specimen could be diluted if a user requests diluent dispense while specimens are being automatically processed in cassette presentation. the dilution may cause erroneous results.
impact:
erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for popu.
Acción
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with PCA Response Form (via US Postal Service for US customers) dated October 20, 2010, to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter describes the product, problem and the following actions to be taken. The customers were instructed to remove all cassettes from the mix station prior to initiating the Diluent Dispense function to prevent the likelihood of a specimen being diluted; do not use pre-diluted samples for RETIC counts; verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and the Body Fluid results are properly validated at the LIS. This will be corrected in a future version; use the lip on the reagent drawer as shown in the picture above; avoid touching the drawer slides while replacing containers; clean all spills promptly to reduce the risk of exposure to blood borne pathogens; complete and return enclosed PRODUCT CORRECTIVE ACTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7503/7504; mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015 or email to: Regulatory.Notifications@beckmancoulter.com, and share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation.
If you have any questions regarding this PCA, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.