Date of event: unknown.The date received by manufacturer has been used for this field.The following is intended to summarize the investigation for customer complaint (b)(4), material 212518, lot 0237774 for precipitate.Components are mixed and dispensed into the appropriate containers.After qc testing product is released and transported to the distribution center.The complaint investigation included a review of the batch history record for tb carbolfuchsin kf.The batch history record review indicated no discrepancies.All release testing was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time there have been no confirmed complaints for the defect in question.Two photos were received.The first photo depicts a view of a bottle of tb carbolfuchsin kf fert # 212518, exp 2021-09-30.The lot number covered by hand holding the bottle.The second photo depicts a bottle of tb carbolfuchsin kf lot # 0237774.A retention sample from the complaint batch was evaluated along with a control batch.The solution appearance was satisfactory and comparable to the control; both were a reddish purple suspension with no visible precipitate, impurities or contamination.Staining was completed per instructions in the product insert.Slides of positive (m.Tuberculosis atcc 25177) and negative (b.Subtilis atcc 6533) controls were evaluated and gave satisfactory staining results with the retention and control batches.The retention was comparable to the control.This complaint cannot be confirmed.
|