The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) issued a medical device alert concerning Oral Fluid Drug Screen Device Saliva Collector manufactured by SureScreen Diagnostics. The affected models are:
The manufacturer is issuing a Field Safety Notice for the Saliva Collector that is an accessory in the Oral Fluid Drug Screen Device. 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.
The manufacturer advises users to implement the Saliva Collector Inspection Process:
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON287037
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 July 2013