Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its UniCel DxH Slidemaker Stainer (DxH SMS) [Part Number: 7755222] and UniCel DxH Slidemaker Stainer II (DxH SMS II) [Part Number: C11477].
The manufacturer is initiating a field safety corrective actions for the affected products. In rare cases if the Sample Aspiration Module (SAM) is not in a safe position while performing cleaning or troubleshooting procedures, the dispense probe may be inadvertently bent. The DxH SMS/DxH SMS II is designed to generate the error message "Stripper Motor movement cannot be verified" and inactivates the Slidemaker when a probe is bent; however, in rare circumstances a slightly bent probe is not detected. This condition may lead to carryover.
The manufacturer has become aware via two customer complaints, and confirmed by its internal investigation, that when the dispense probe is slightly bent, residual blood from a sample may be left behind on the edge of the dispense path. When the dispense probe moves to deposit the next sample blood drop, the dispense probe may come in contact with blood from the previous sample.
Users are advised to perform the steps mentioned in the field safety notice to determine if users are affected by the issue and consult with their Medical Director to determine if a retrospective review of results is warranted. In the future, any time the affected users are performing troubleshooting or cleaning procedures that require opening the front cover, follow the steps to confirm that the dispense probe is not bent.
In accordance with product labeling, when accessing the DxH SMS/DxH SMS II during operator troubleshooting or cleaning procedures, the affected users should ensure that the SAM is powered OFF and moved completely out of the way before pulling out any module. They should follow the steps for each troubleshooting or cleaning procedure in the Instruction For Use or System Help to properly place the SAM in a safe position.
The manufacturer has a hardware change in progress to eliminate the possibility of carryover from a slightly bent dispense probe which is projected to be available starting in December 2019.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 October 2019