Alinity i Processing Module (2019-04-09)

Starting date:

April 9, 2019

Posting date:

April 18, 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-69652

Last updated: 2019-04-18

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  Reason
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  Affected products

Affected Products

Alinity i Processing Module

Reason

There is a potential for loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. A loose cable connection has the potential to heat up and cause damage to the wire and connector. If this occurs, the operator may detect a burning smell. The cable connection to the reagent cooler is located within the processing module and is not intended to be accessed by the operator. Due to the very low flammability rating of the materials used, any heat damage would be localized to the connectors. The cable connections on the reagent cooler have been redesigned to include more robust connectors.

Affected products