UniCel DxI Access Immunoassay System Information UpdateSeptember 2008ĭaily Washed System CheckAdd this procedure to your DxI daily maintenance procedures until further notice. Sincerely,ĭave King Quality / Regulatory Affairs Northern Region Europe Tel 01494 429184/01494 42914 429182 Enclosures (2): System Check Instruction, Response Form Thank you for your continued support of Beckman Coulter products. We sincerely apologise for any inconvenience that this may have caused your laboratory. If you have any questions regarding this notification, please contact your local Beckman Coulter representative. Whether or not you have an affected pump, please complete and return the enclosed Response form within 10 days so we can be assured that you have received this important notification. Please share this information with your laboratory staff and retain this letter for your Quality System documentation.
If the washed routine results are not as expected, follow the troubleshooting instructions in the attached procedures. If the washed routine results are as expected, continue daily processing. Instructions are in the attached Daily Washed System Check information update.
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For instruments with matching serial numbers, please run the washed portion of the system check routine every 24 hours, as part of daily maintenance, until the pumps are serviced.
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If you have a serial number that is not listed, that instrument does not have an affected pump and you do not need to complete step 2. To view the instrument serial number, select Configure F8 from the Main Menu, and then select System Setup F1. Verify that each serial number listed on the enclosed Response form matches a serial number on a DxI instrument in your lab. Please take the actions listed below until this service occurs. We will contact you to arrange a date to service the affected pumps as soon as possible. We are investigating potential solutions to this failure. The upper peristaltic pump assembly may not maintain a proper flow rate.
Our records indicate that you have an instrument with one of these pumps. The failure is limited to those UniCel DxI 800, DxI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg.
Premature failure of the pump may negatively affect precision. A62712, A62839, A62840, A62841, and A63124Dear Beckman Coulter UniCel Customer: We have confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. URGENT: PRODUCT CORRECTIVE ACTIONUniCel DxI 800 and UniCel DxI 600 Access Immunoassay Systems and UniCel DxC 880i SYNCHRON Access Clinical SystemPeristaltic Pump Mfg.
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