UniCel DXH Slidemaker Stainer and UniCel DXH Slidemaker Stainer II Coulter Analysis System (2019-10-02)

Starting date:

October 2, 2019

Posting date:

January 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71971

Last updated:
2020-07-10

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  Reason
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  Affected products

Affected Products

A. UniCel DXH Slidemaker Stainer

B. UniCel DXH Slidemaker Stainer II Coulter Analysis System

Reason

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.

Affected products