BenchMark ULTRA instruments (2019-01-23)

Starting date:

January 23, 2019

Posting date:

March 1, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69174

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  Reason
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  Affected products

Affected Products

BenchMark ULTRA instruments

Reason

In rare event the instrument reagent carousel loses alignment due to an electrical or mechanical failure, the software may not always report the failure. The reagent carousel misalignment can lead to the application of the incorrect reagent or to no reagent dispensing on the slide.

Affected products