Medical device manufacturer, Trinity Biotech, has issued a field safety notice concerning Captia™ Varicella-Zoster Virus IgG Kit. The affected kit lot numbers are 2325600-566, 2325600-567, 2325601-566 and 2325601-567.
The manufacturer noted that a drop in absorbance value of the Calibrator may occur. This could result in an invalid test run, with the Calibrator running low causing the Positive Control to run high out of its assigned ISR range. If the test resulted in a valid run, such as all kit Controls and Calibrator met Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results was not necessary.
According to the local supplier, Tin Hang Technology Limited, the affected devices were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 11 June 2012