Sorry for the delay in responding - I have been away for a couple of days.
Both issues were covered in a Dear Customer letter dated 24th November that was sent out by Nipon BCG.
The endotoxin issue can be easily dealt with by not adding endotoxin to the tubes which I assume Cellestis/Greiner are now doing.
However, the shaking issue is not so easy. The Dear Customer letter states (translated):
"After our investigation, we have identified that those results occur if you shake the tube too fiercely. Therefore, we have revised our product manual and hereby we have resumed the sales of the product".
Unfortunatly the tubes do have to be shaken quite vigorously to disolve the antigens into the blood so customers have to work out what is hard enough to disolve the antigens but not so hard as to disrupt the gel.
It is interesting that other countries have not seen the gel issue. One thought is that the hospitals (and buildings in general) in Japan are often hotter than in other countries so maybe this will only be seen in Japan.
Anyway, I expect this issue will be reported again at some stage.
Alex
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