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:

• ORAT6V1 ORAL SCREEN (OPI/AMP/MAMP/COC/THC/MTD)
• ORAT2 ORAL SCREEN (OPI/COC)
• ORAT6V2 ORAL SCREEN TWIST DEVICE (OPI/AMP/MAMP/COC/THC/PCP)
• ORAT4 ORAL SCREEN (COC/AMP/THC/OPI)
• ORAT6V3 ORAL SCREEN TWIST DEVICE (COC/MET/BZO/THC/OPI/AMP)
• ORAT6V4 ORAL SCREEN TWIST (COC/THC/MAMP/MTD/OPI/AMP)
• ORAT3V2 ORAL SCREEN TWIST (COC/MET/THC)
• ORAT6V5 ORAL SCREEN TWIST (COC/MAMP/OPI/AMP/MTD/BZO)

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:

• Before using the affected Saliva Collectors, gently pull the sponge while it is in the wrapper to ensure it remains firmly attached to the handle. Immediately discard any Saliva Collectors if the sponge detaches from the handle.
• Alternatively, contact the manufacturer for replacement product.

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