Medical device manufacturer, Iris International, has issued a medical device safety alert concerning its iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips [Reference number: 800-7212; 800-7212-001; 800-7204; 800-7204-FJR].

The manufacturer has become aware of loose or missing analyte pads being found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System. If affected strips are used to assay patient samples, the issue has the potential to cause erroneous pH results and false negative results for the following tests: nitrite, glucose, blood, bilirubin, urobilinogen, protein, leukocyte esterase, ketones, and ascorbic acid. There is no impact to the measurement of colour, clarity and specific gravity.

Affected users are advised to take the following actions:-

• When loading strips, observe for loose or missing analyte pads; if loose or missing pads are observed, discard the vial and do not use the strips from that vial.
• In addition to regularly scheduled maintenance, the laboratory should determine a schedule to periodically check the strip provider module, strip conveyor system, and waste container for pads that may have fallen off during processing.
• Furthermore, if pads are found in the strip provider module, strip conveyor system or waste container, service should be contacted to rule out any instrument operational issue.
• A retrospective review of results may be clinically warranted for those samples that were tested with strips that were subsequently known to have missing pads. Laboratory Director should be consulted to determine if further retrospective review of results is clinically warranted with particular consideration to situations in which inconsistencies appear to exist between clinical conditions, results of other laboratory tests, or other urine analytes.

Product replacement is on-going.

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 26 January 2016