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There was no change to patient treatment attributed to this event. Through troubleshooting with customer technical support (cts), it was determined that the s0 calibrator rlus (relative light unit) were higher than in-house qc release data.įor sandwich assays such as hybritech psa, this can cause a shift down in qc and patients' samples.Ĭustomer was advised to re-calibrate once more with a fresh box of calibrator of the same lot number and to repeat the patients' samples.Īll four patients which had previously given ind flags recovered 0. Later that evening, the customer had 4 patient samples which gave ind flags for psa.Ĭustomer recalibrated psa on (b)(6) and reran patient samples but still obtained ind flags.
DXI BECKMAN COULTER DOWNLOAD
You can download a raw copy of the database here.Customer called on (b)(6) 2012 reporting of no value results/ind (indeterminate) flags for hybritech psa (prostate-specific antigen) on four patients' samples generated on the unicel dxi 800 access immunoassay system.Ĭustomer stated on (b)(6) 2012, customer has had service for a high substrate mean and the luminometer on the instrument was adjusted.Ĭustomer indicated that all assays were then recalibrated and qc was run on all assays successfully. Always cite the International Consortium of Investigative Journalists when using this data. This reference table contains information for assays that utilize the onboard dilution.
DXI BECKMAN COULTER LICENSE
The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. For use with the UniCel DxI 600 and 800 immunoassay systems only. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. The same device may have different names in different countries. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Medical devices help to diagnose, prevent and treat many injuries and diseases. Outside the United States and Canada, contact your local Beckman Coulter Representative.Įxplore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.ĭo you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. Seamlessly integrates with Beckman Coulter Analyzers. If they need assistance or have any questions regarding this notification, customers were told to contact Technical Support at 1-80 in the United States or Canada. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that consignees received the notification.
DXI BECKMAN COULTER SOFTWARE
Customers may wish to confirm that proper ranges and units of measure are being reported for any Access assays with sample type settings that were changed while running software version 4.3.Ĭustomers were asked to share this information with their laboratory staff, and retain the notification as part of their laboratory Quality Ststem documentation. Refer to the attached Questions and Answers document for additional details and instructions, and to determine if their laboratory is running UniCel DxI Sytem Software version 4.3. See the appendix included with this letter for additional information. Until the new software version is available, Beckman Coulter has provided an alternate method for changing the default sample type setting. Customers were instructed to:Ī revised version of UniCel DxI System Software that corrects this issue is currently in development. The letter provides the customers with an explanation of the problem identified and an action to be taken. Beckman Coulter forwarded on 7/6/10 a Product Corrective Action letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the UniCel Dxl 600 and Dxl 800 Access Immunoassay systems.