Alinity i Processing Module (2018-09-18)

Starting date:

September 18, 2018

Posting date:

October 5, 2018

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-67896

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  Reason
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  Affected products

Affected products

Alinity i Processing Module

Reason

Abbott has identified an issue with the Alinity i bulk solution Dispense Pumps (part number A-35001280-01) resulting in pump failures. The issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution(s) that eventually results in the pump failure. The amount of the leakage does not impact the ability of the pump to accurately dispense bulk solutions, and the leakage is contained within the service-only area of the instrument. Therefore, this issue does not pose a risk of incorrect results or a risk of physical exposure to the operator. The failure of this pump could result in unexpected instrument down time potentially causing a delay in generating results.

Affected products