Alinity hq Analyzer (2019-03-22)

Starting date:

March 22, 2019

Posting date:

April 18, 2019

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-69626

Last updated: 2019-04-18

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  Reason
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  Affected products

Affected Products

Alinity hq Analyzer

Reason

This device is being recalled due to potential issues with the Alinity hq analyzer incubation paddles. There is a potential for delay in the generation of patient results due to the increase in "step loss on axis" errors and seizing of the incubation paddle. There is also a potential of impact to patient results due to the foaming of the reagent in the incubation cup.

Affected products