[cameldrv]

No this is normal. When you introduce a new diagnostic test, part of the approval process is that you have to run an aging study on the reagents/test cartridge.

The normal procedure is to set some of the tests aside when they first come off the production line. Typically every six months, you run a new study to validate that the tests you set aside still work. If they do, you can file an amendment to your approval to extend the expiration date. If this weren't allowed, you'd have to wait to bring your test on the market for two years or however long you wanted the shelf life to be.