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Email an electronic copy (.CSV) of the control file to Include the IQAP number on any communication. Fax printouts of the missing files to 78 Submit your data at the electronic IQAP website (eIQAP) at
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Instead, submit the missing file(s) by one of the following methods: Ensure an alternative method of analysis is available during database maintenance.įor Issue 3, customers were instructed to not attempt to transmit the files again after receiving an incomplete report.
#Beckman coulter iqap manual#
For Issue 1 & 2, customers were instructed to perform manual database maintenance procedures to locate and delete unnecessary patient result and demographic information that extends beyond the life (in days) of the control lots. The letter provides customers with an explanation of the problem identified and an action to be taken. The recall communication was initiated on 4/12/11 with Beckman Coulter forwarding an Urgent Product Correction (PC) letter with attached PC Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel¿ DxH" 800 Coulter¿ Cellular Analysis System PN 629029. The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old. Unicel¿ DxH 800 Coulter¿ Cellular Analysis System.Ī quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Class 2 Device Recall UniCel DxH 800 Coulter Cellular Analysis Systemĭifferential Cell Counter - Product Code GKZ