Medical device manufacturer, Abbott Laboratories, has issued a medical device safety alert concerning its Alinity s System [List Number: 06P16‐01; Serial Number: All].
The manufacturer has identified potential performance issues for the Alinity s System software version 2.5.0 and earlier and is releasing Alinity s System software version 2.6.0 (LN 04U76‐12) to correct these issues. (Users should refer to Appendix A of the manufacturer's Field Safety Notice (FSN) for details related to the identified issues with the Alinity s System Software version 2.5.0 and any donor / patient results or user safety impact.)
In addition, the manufacturer has identified the need for a hardware improvement related to the reagent 2 (R2) pipettor cable raceway, a component of the reagent 2 pipettor gantry. The raceway can begin to crack after prolonged use. The manufacturer has released a durable chain to replace the raceway, which will alleviate the potential for premature failure. Failure of the R2 pipettor cable raceway during instrument operation can cause a collision between sample carriers and result in splashing, thus leading to the potential for biohazardous exposure and the potential for incorrect test results.
The manufacturer will be scheduling a mandatory upgrade of Alinity s System to install Alinity s System software version 2.6.0. Until the upgrade is complete, affected users should refer to the actions within Appendix A of the FSN.
The manufacturer will also be scheduling a mandatory hardware upgrade of the Alinity s System to replace the R2 pipettor cable raceway. The "Alinity s System Operations Manual" provides instructions for addressing spillage in Section 8: Hazards, and provides corrective actions associated with potential message codes and erratic results in Section 10: Troubleshooting.
Affected users should follow the laboratory procedures and retain the FSN for laboratory records.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 March 2020