Provue Recall

[jch]

Has anyone heard anything about a Provue recall from last week?

[heathervaught]

I don't see anything on the FDA-CBER website: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm

[DFields]

The recent software upgrade has 2 problems that were discovered after it was released and installed:

these are about (I have not worded them precisely):

1. lot number changes of reagent cells are not flagged

2. if there is a certain error flag on a card, the last well in that card will not have sample dispensed--this would be obvious in a reverse type or antibody screen (would be NRD) but in a panel the last cell could be a false negative since no sample was dispensed.

The notification came from Ortho to users last week. We went back through panel results to make sure that error flag was not on any of those runs since the software upgrade was installed.

[Eagle Eye]

We were one of the first place to get the new software v3.1. I need to look at ~5 months data. I am asking Ortho to help me with it. I am not really worried that much because we do not run panels , crossmatches on ProVue.

All other cases anytime my techs gets "#" symbol we repeat the tests.

About the second recall----where if you have two different lot# of reagent red cells on ProVue same time ProVue will not flag.....we never put more than one lots of same reagents on ProVue.