Alinity ci-series System Control Module (2019-06-13)

Starting date:

June 13, 2019

Posting date:

June 28, 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-70321

Last updated: 2019-06-28

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  Reason
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  Affected products

Affected Products

Alinity ci-series System Control Module

Reason

Abbott has identified an issue with all on-market versions of Alinity ci-series Software where re-use of reaction vessels (RVs) may occur after a system Stop. This issue only occurs if the system is transitioned from Processing to Stopped to Idle and has the potential to cause incorrect results.

Affected products