cmv, page-15

G'day alexanders,

Both of these issues are well known and have been dealt with.

The endotoxin issue was a contamination issue in one batch by the manufacturer (BD). A very small number of tests reported false positive because of this. The batch was immediately recalled and the manufacturer has implemented procedures ensure no future recurrence.

The "shaking issue" is totally independent. This was not a problem with the tubes or the process itself. It was a translation issue with the documentation. Apparently, "shake well" translates to "shake the bejezus out of it". Embarrassing, but it has now been resolved with new documentation and training. It has nothing at all to do with temperature. The reason why it was only experienced in Japan and not anywhere else is purely because of the documentation translation into Japanese.

The In-tube product has now been re-launched in Japan and I have not been made aware of any ongoing problem consequent on those two aforementioned issues.

Alexanders, if you believe there is something that I am missing, I would be happy to discuss it further with you - my email address is forrestthinks (at) gmail (dot) com