Alinity Ci-Series System Control Module (2018-08-07)

Starting date:

August 7, 2018

Posting date:

August 24, 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-67596

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  Reason
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  Affected products

Affected products

Alinity Ci-Series System Control Module

Reason

Alinity ci-series Software Version 2.5.0 (List Number 04V20-03) contained changes to how the Alinity i processing module handled process path movement issues. After installing this new software version, customers have reported an increase in the occurrence of message code 5752: "Process path move error on (0) lane. 0 = Process path lane." When this message code occurs, all tests are sent to exception. Recovery from the error requires the operator to initiate or resume sample processing on the Alinity i processing module. The increase in the message code 5752 is due to a less effective auto-recovery procedure contained in software version 2.5.0. Software Version 2.5.1 (List Number 04V20-05) is now available. This software version will restore the previous auto-recovery procedure. This software version will not eliminate all process path jams if some underlying hardware issue restricts the process path movement, but it will reduce the occurrence of message code 5752.

Affected products