ALINITY I PROCESSING MODULE (2017-10-13)

Starting date:

October 13, 2017

Posting date:

October 27, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-64958

• Reason
• Affected products

Affected products

ALINITY I PROCESSING MODULE

Reason

Abbott has identified the potential for a loose cable connection on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. The loose cable connection has the potential to heat up over long periods of time and cause damage to the wire and connector. This would be detected by the operator in the form of a burning smell. The cable connection to the reagent cooler is located within the processing module and is not accessed by the operator. Due to the very low flammability rating of the materials used, the heat damage is localized to the connector.

Affected products