[9215]
One hundred eighty-nine of box one of the kit were packaged between 6/29 and 6/30/94, inspected prior to release, and 181 of box one of the kits were released to finished goods inventory on 6/30/94. Twenty-five kits were shipped on 6/30/94 for next day arrival on 7/1/94. On the next working day, 7/5/94, while staging a packaging assembly for another product, it was discovered that the component reagents were missing from work-in-process (wip) inventory. The missing reagents were 37 bottles of 10x denaturation solution, cat no s4062, lot #4d127, and 37 bottles of 10x depurination solution, cat #s4061, lot #4d129, which happened to be similar reagents to those used in the kit. A check of that inventory, revealed that 101 out of 227 10x depurination solution bottles remained in inventory. A hold was placed on the remaining kit inventory. Of the 156 finished goods inventory boxes, one production retain and 7 qc retains, 71 kits were found to have the wrong reagent in the 10x depurination solution canister. Because all 37 of the 10x depurination solution lot were recovered and only 34 of the 10x denaturation solution were recovered, co concluded that there were still possibly 3 kits within the 25 which had been distributed that may contain the wrong reagent. A technical evaluation of the extent of the problem was made and a plan was devised to contact each of the 15 consignees receiving the 25 kits. Co was 100% effective in contacting all consignees and recovering all switched reagents. All units were recovered prior to customer use.
Patient Sequence No: 1, Text Type: D, B5