Newcastle Laboratories

Field Safety notice: Leaking COBAS PCR Medic Tubes in kits.

Roche regrets to inform users that a higher than expected number of complaints have been received regarding leaking COBAS PCR Media tubes in various lots of COBAS PCR Media Dual Swab Sample Kits, COBAS PCR Media Uni Swab Sample Kits & COBAS PCR Urine Sample kits.

The leakage can result in visible crystallisation near the cap closures and/or droplets within the packaging.  The situation does not represent a safety concern.  Roche is requesting users inspect and discard any leaking vials of COBAS PCR Media Tubes.  As stated in kit inserts, users are reminded not to use damaged or leaking COBAS PCR Media Tubes or damaged swabs.  Discard the affected tube and use a new one.  Additionally, users should wear protective gloves/eye protection/face protection when handling the kit reagents.  Should users have any leaking vials of COBAS PCR Media Tubes, please contact Roche via the technical support hotline 0808 100 19 20, free of charge replacements will be issued for any affected kits.

Roche has initiated a root cause investigation and corrective measures have been implemented.  

Please contact Microbiology & Virology Service, Freeman hospital, if you have any concerns regarding this issue.