Events

Safety Alert for iChemVELOCITY Urine Chemistry Strips

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Iris International.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-01-26
  • Event Date Posted
    2016-01-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160126.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: iris international ichemvelocity urine chemistry strips 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.

Device

iChemVELOCITY Urine Chemistry Strips
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Iris International iChemVELOCITY Urine Chemistry Strips
  • Manufacturer
    Iris International

Manufacturer

Iris International