Correction/removal number= 3002809144-03/16/20-002-r. Investigation into the issue confirmed a performance shift for the architect havab-g impacted reagent lots due to the erroneous concentration for hepatitis a virus that was utilized during manufacture, which has the potential to generate falsely elevated control and patient sample results. An internal study using anti-hav negative patient samples was conducted and determined that results that fall in the range of 1. 00 - 1. 72 s/co have the potential to be falsely reactive. A product recall letter has been issued to all customers who have received the impacted lots 03429be00, 06172be00, 08073be00, and 10353be00. The product recall letter instructs the customer to immediately discontinue the use of, and destroy, any remaining inventory of the specific 4- architect havab-g reagent lots and instructs the customer to contact customer support for replacement material in the event if they were currently using or have inventory of one of the impacted lots.
Patient Sequence No: 1, Text Type: N, H10
The account reported they were having issues with the architect havab-g reagent, lot 10353be00. The customer stated that the negative/positive quality controls passed but displayed poor recovery during correlation studies. After review, the borderline results seemed to be running higher with lot 10353be00 when compared to a different lot. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5