Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its IMMAGE Immunochemistry Systems Cuvette Sectors [Part number (P/N): 470706; all Lot].

The manufacturer has determined that IMMAGE Cuvette Sectors (P/N 470706) may be missing one of two positioning pins. Cuvette Sectors missing a positioning pin can become misaligned. If a Cuvette Sector becomes misaligned, under rare circumstances, the instrument mixer paddle may rub against the inside wall of the Cuvette and create a noise. The manufacturer has no evidence of erroneous results being generated due to this issue to date.

The manufacturer is instructing affected users to take the following actions:-

• Inspect the Cuvette Sectors on the instrument reaction wheel to determine if any are missing positioning pins. Replace any Cuvette Sectors with missing pins. Upon completion of inspection, confirm that all Cuvette Sectors are seated in the reaction carousel.
• Inspect the spare parts inventory of Cuvette Sectors to determine if any are missing positioning pins.
• Discard any Cuvette Sector with missing positioning pin.
• A retrospective review of results is not necessary.

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 01 March 2017