Summary of complaint investigation for complaint ticket (b)(4).Investigation into this complaint included an evaluation of the quality data review, complaint history review, and inspection of abbott molecular (am) retains from the same lot of material in question.Related manufacturing and test records were reviewed, and no errors were identified.The manufacturing process is a manual process.Slides are 100% inspected at the kit manufacturing stage.Once placed into kits, the kits are sampled and inspected by quality control.No issues were noted during inspection.In addition, a process is in place to minimize damage during shipment of slides from am.A visual inspection using am retain samples from the same lot of material in question was performed to determine if products had any visually identifiable damage.No damage was identified.Aside from the complaint currently being addressed by this investigation, two additional complaints reporting broken/damaged slides were reported in the last 12 months.The current complaint rate for broken slides is 0.04% (3 complaints for broken slides for 7,511 units sold), indicating that the issue may be seen with a frequency of "occasional." based on the results of investigation no systemic product deficiency has been identified.
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