Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning the Saliva Collector that is an accessory in the Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line Screen Test Device, manufactured by Innovacon, Inc. The affected kit lot numbers are DOA3010115, DOA3030337, DOA3030682, DOA3030529 and the affected lot numbers of the Saliva Collector are B121208, B130103, B130104, B130101.

In certain lots, the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk. The manufacturer's investigation indicates that the sponge may become dislodged on approximately 5% of the Saliva Collectors from affected lots. To date, there have been no reports of individuals swallowing or choking on the sponge during use.

The manufacturer advises the affected users to:

• gently pull the sponge while it is in the wrapper before using the Saliva Collectors for the lots specified above and ensure it remains firmly attached to the handle;
• immediately discard any Saliva Collectors if the sponge detaches from the handle; and
• ask for a replacement product if they are not willing to perform the inspection steps.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON286923

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

Posted on 25 June 2013