Medical device manufacturer, Abbott Diagnostics, has issued a medical device safety alert concerning its Instrument Manager [List Number: 03P23; Serial Numbers: 340534, 344571, 340456, 341105, 343400].

The manufacturer has received the information from Data Innovations, Manufacturer of Instrument Manager regarding QC results transmission between Instrument Manager (IM) and Alinity ci interface.

According to the manufacturer, when Alinity ci instrument transmits result from a Quality Control (QC) Sample ID (Q^Control in SPM segment), the IM Alinity ci driver (v8.00.0001) does not parse the results, resulting in QC data not going into IM. This happens when the driver configuration "Hold Results Until Complete" feature is enabled. All affected users using the Instrument Manager software, List Number 03P23, with Alinity ci‐Series interface driver name: abdicqii, v8.00.0001 may be impacted. This issue was identified via a complaint.

The affected users are advised to take the following workaround instructions.

• To disable the "Hold Results Until Complete" option in Instrument Manager (driver configuration).
• For version IM 8.14.10, use Getting Started Setup Guide page 45 "Editing a Driver Configuration" and Alinity ci v8.00.0001 Driver Help File "HRUC Configuration" to disable this option.
• For IM 8.15.11, use "Editing A Driver Configuration" web user guide and Alinity ci v8.00.0001 Driver Help File "HRUC Configuration" to disable this option.
• Ensure that "Hold Results Until Complete" is disabled for every license number of Instrument Manager software versions listed above and installed in your laboratory regardless of its use (production and test environments).

The manufacturer's representative will be contacting the affected users to apply the updated (v8.00.0002) version of Instrument Manager driver to correct this issue.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 2 October 2018