The complaint investigation for the alinity hq processing module included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A review of customer data aligned with the customer¿s issue and no additional issues were identified.A search for similar complaints did not identify an increase in complaint activity.Trending review did not identify any trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Review of the data on the alinity hq processing module found that the lym, mono, and baso parameters were flagged as suspect/invalid and blast, mono & baso boundary not found flags were generated.Additionally, the alinity hq flagged for blast.The customer also ran the same sample on the advia and several rbc and wbc flagging for abnormal cells were also observed for the run on the advia.No smears were provided for review.Based on our investigation, no systemic issue or deficiency with the alinity hq processing module for serial number (b)(6)was identified.
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