Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency(MHRA), United Kingdom posted a field safety notice concerningORTHO BioVue System Cassettes, manufactured by Ortho Clinical Diagnostics.

Ortho Clinical Diagnostics has identified isolated occurrences of improperly positioned cassette labels for certain products.An investigation confirmed that the cause of the issue occurred on one of our three manufacturing lines following a particular sequence of events.The occurrence rate of the issue is very low.

The use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. There is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent.

The manufacturer advises users to

• inspect all cassettes from the potentially affected lots remaining in facility prior to use, by referring to the ORTHO BioVue System Cassette Inspection Procedure for visual detailed instructions; and
• do not use cassettes with an incorrectly positioned label and discard the affected cassette in accordance with local regulations.

According to the local supplier, the affected products were distributed in Hong Kong.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON287036

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 9 July 2013