Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a Field Safety Notice concerning Cobas TaqScreen MPX Test, version 2.0, manufactured by Roche Molecular Systems, Inc.

According to the manufacturer, the Package Insert, Part No. 05969492190, v.2.0, used with the cobas TaqScreen MPX Test, version 2.0 for use on the cobas s 201 system, CE-IVD contains incorrect specimen transport stability parameters. The Living Donor Specimen Transport Stability claim in the Specimen Collection, Storage and Handling section of the cobas TaqScreen MPX Test, version 2.0 CE Package Insert currently allows users to store blood collected in EDTA, CPD, CPDA1 or CP2D for up to 72 hours at 2-30 °C. The Package Insert will be revised to inform users that blood collected in EDTA, CPD, CPDA1 or CP2D can only be stored for up to 48 hours at 2-25 °C.

The manufacturer advised users to immediately take the following actions:

• Users should begin using the new specimen transport conditions as below:
  • Blood collected in EDTA may be stored for up to 48 hours at 2 - 25°C.
  • Blood collected in CPD, CPDA1 or CP2D may be stored for up to 48 hours at 2 - 25°C.
• Whole blood samples with HCV titers near 20.4 IU/mL or lower stored under conditions stated above, should be reviewed, as, although unlikely, they possibly could have been impacted by this issue.

Furthermore, product labeling will be updated with the next kit build by the manufacturer.

For details, please refer to MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON195873

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

Posted on 25 October 2012