Important Safety Alerts

Medical device manufacturer, Iris International, has issued a medical device safety alert concerning its IRISpec CA/CB/CC and IRISpec CA/CB. The affected products are identified as follows:-

• Reference Number: 800-7211
  • Lot Numbers: 336-15, 343-15 (Exp April 2016)
  • Lot Numbers: 004-16,006-16,019-16,021-16,182-15 (Exp May 2016)
• Reference Number: 800-7702
  • Lot Numbers: 313-15, 336-15 (Exp April 2016)
  • Lot Numbers: 004-16 (Exp May 2016)
• Reference Number: 800-0074
  • Lot Number: 309-15 (Exp April 2016)

The manufacturer has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the IRISpec CA bilirubin control material. The control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until QC passes. There is no impact to patient results.

The manufacturer is advising users to ensure the directions for handling and storage of the control material as per the Instructions for Use are followed to prevent premature degradation of the control material. Users are advised to discard the bottle if the IRISpec CA control for bilirubin fails and use alternative bottles in the kit. If the problem persists, users are advised to request a product replacement from the manufacturer.

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 18 April 2016