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Darren

AlbaQ-Chek Controls Question

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I recently received a notice that Quotient has updated the IFU for the AlbaQ's.

They removed the line: "Once opened, vials can be used for seven days."

They replaced it with: "Once the product vials are opened, the reagent's performance characteristics are maintained for seven days when stored at recommended temperatures within its original vial."

To me this opens up the possibility of using them until the reagent expiration date. Of course that would depend on a validation study. I've kept old ones around and they seem to never lose their reactivity. Even to the point that they rarely suffer from lowering grades as they age.

Thoughts?

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I would think that the rephrasing was to emphasize that is is the reagent in the vials (not just the vials themselves!) that expires after 7 days.  I think it is clear that they are saying they claim the reagent is stable for 7 days after opening.  If I were an inspector, I would interpret the new phrase as indicating that the "performance characteristics" end after being "maintained" for 7 days, which would mean that you cannot use a vial after that time.

Scott

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23 minutes ago, SMILLER said:

I would think that the rephrasing was to emphasize that is is the reagent in the vials (not just the vials themselves!) that expires after 7 days.  I think it is clear that they are saying they claim the reagent is stable for 7 days after opening.  If I were an inspector, I would interpret the new phrase as indicating that the "performance characteristics" end after being "maintained" for 7 days, which would mean that you cannot use a vial after that time.

Scott

This is the problem with peer to peer inspections, I interpret it differently and unfortunately the wording is less precise than previously and open for interpretation. Interpretation, though well-informed, is still opinion. The new line doesn't say that the performance characteristics end or that it cannot be used after seven days. It would seem that a lab could validate them for longer use as long as they did a decent study and include things like examining for hemolysis, reactivity strength over time, etc. So far I can't get the updated PDF from the Quotient website.

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I received the same notification yesterday and asked my Quotient rep as the IFU being shipped is the same January 2019 revision as is on the Quotient BD website. The answer was to call the Ortho Customer Service line to ask for the date of the future implementation.  The original notification is dated May 2, 2019 for an August 2019 implementation.  The timeline has obviously changed to some future date which is not being disclosed at this time.

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I interpreted it that they added that it had to be stored in it's original vial and stored appropriately at the recommended temperature.

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10 minutes ago, Texas Lynn said:

I interpreted it that they added that it had to be stored in it's original vial and stored appropriately at the recommended temperature.

I would think that if that were the case it should say:

"Once the product vials are opened, the reagent's performance characteristics are maintained for seven days when stored at recommended temperatures and within its original vial. Do not use this product after seven days of being opening."

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