Alinity ci-series System Control Module (SCM) (2018-07-13)

Starting date:

July 13, 2018

Posting date:

July 27, 2018

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-67308

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  Reason
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  Affected products

Affected products

Alinity ci-series System Control Module (SCM)

Reason

Abbott has identified the following issues with the Alinity CI-series which may present a potential performance issue in Alinity CI-series Software version 2.10. Abbott is releasing Alinity CI-series Software version 2.50 to correct these issues.

1. Removing racks during the Maintenance state is not detected by the system. Issues with orders may occur when reloading a rack with samples and returning to Running state.

2. Orders created using more than one of the I-series, C-series, or calculated options to select assays will only include the assays selected in the last filtered view, if the order is saved prior to returning to the All option.

3. Enabling an assay when the processing module is in the Running or Processing status causes the assay to be re-installed.

4. A sample with 270 test orders remained in the Scheduled status and would not process.

5. Some maintenance and diagnostic procedures can appear to have completed successfully when there was insufficient inventory.

Affected products