Medical device manufacturer, Iris International, has issued a medical device safety alert concerning its iChemVELOCITY Automated Urine Chemistry Systems [Reference numbers: 800-3564, 800-7100, 800-7103, 800-7162, 800-7163, 800-7166, 800-3061], equipped with Color/Clarity/Specific Gravity Module (CGM) [Part numbers: 700-7602, 700-7611, B93997].

According to the manufacturer, the concerned iChemVELOCITY system detects and reports 11 colours as opposed to the 18 listed in the iChemVELOCITY Operator's Manual. If the instrument is equipped with any of the part numbers listed above:

• The following urine colours will be detected and correctly reported: colourless, straw, light yellow, yellow, dark yellow, light amber, amber, dark amber, red, blue, and green
• The following urine colours will not be detected or reported: orange, light brown, brown, dark brown, light red, dark red, other

If the urine colour orange, light brown, brown, dark brown, light red, dark red or other colour than those listed as 'can be detected and reported' is visually observed during processing. The customers are recommended to take the following actions:

• Consider reporting the visually observed colour reading using the user's laboratory reporting system (e.g. hardcopy, LIS).
• Consider using an approved back-up analyzer to process and report these samples if the colours above are needed within the user's laboratory.

The manufacturer will update the iChemVELOCITY Operator's Manual to reflect colours that can be detected and reported by CGM part numbers listed above.

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 11 April 2017