All available patient information was included.Additional patient details are not available.Correction/removal number= 3002809144-03/16/20-002-r.Investigation into the issue confirmed a performance shift for the architect (b)(6) impacted reagent lots due to the erroneous concentration for (b)(6) virus that was utilized during manufacture, which has the potential to generate falsely elevated control and patient sample results.An internal study using (b)(6) 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 (b)(6) 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.
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The customer reported patient correlations were recovering with discrepant results with the use of the architect (b)(6) reagent lot 06172be00.The following data was provided (s/co): sid (b)(6) - 0.60 1.14, 1.31, 1.61; sid (b)(6) - 0.73 1.29, 2.05, 1.21; sid (b)(6) - 0.88 1.45.Additionally, the customer reported that quality controls (qc) shifted high but in range with lot 06172be00.There was no impact to patient management reported.
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