Medical device manufacturer, Abbott, issued a medical device safety alert concerning its Alinity s Systems [List Number: 06P16-01; Serial Number: AS1001—AS1355].

The manufacturer has identified a potential issue with Alinity s System software versions 2.7.1 and prior. The manufacturer is releasing Alinity s System software version 2.8.0 (LN 04U76‐15) to correct this issue. The Alinity s System Operations Manual, Section 9, Service, maintenance, and diagnostics, states Maintenance and Diagnostics (M&D) procedure 8900, Pipettor Probe Replacement, is performed when replacing the sample or reagent (R1, R2) pipettor probes. For the sample and R1 pipettor probe replacement options, the upper loading area opens after the pipettors are moved into the replacement positions to allow the operator access to the pipettors for probe replacement.

According to the manufacturer, the issue will not cause incorrect donor / patient test results. When M&D 8900 is initiated from the Stopped state, and the R1 pipettor probe is not straight, and there is a loaded sample rack on the aspiration platform, the potential exists for biohazardous exposure (spill) and / or operator injury (broken sample tube). The upper loading area is not accessible by the operator until the sample and R1 pipettor probes are in the designated replacement positions. The operator could be exposed to breakage and / or spillage within the instrument upon accessing the upper loading area to perform pipettor probe replacement.

The manufacturer will be scheduling a mandatory upgrade of the Alinity s System to install Alinity s System software version 2.8.0. Users should refer below for the necessary actions to follow when utilizing the Alinity s System prior to the software v2.8.0 upgrade:

• Prior to initiating M&D 8900 to perform sample and / or R1 pipettor probe replacement from a Stopped state, remove sample racks from the processing center.
• As stated in Section 8, Hazards, of the Alinity s System Operations Manual, follow all product labeling and safety instructions in the laboratory. Always wear personal protective equipment (PPE) when operating the Alinity s System, other laboratory instrumentation and equipment, and when using chemicals.

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

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

Posted on 21 Oct 2021