Health Canada — Medical Devices · Canada · 2020-01-06 · Type II
As described by Health Canada — Medical Devices: UniCel DXH Slidemaker Stainer and UniCel DXH Slidemaker Stainer II Coulter Analysis System (2019-10-02)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: 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. 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.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.