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Holding & Distribution and Traceability

Section 211.142 requires that the manufacturer be able to trace the lot number of product in order to facilitate a recall of a product. In the 610 sections (shown below), there are specific requirements for tracing a donor unit to the recipient and a requirement to notify the transfusing facility in the event that a donor subsequently tests positive for HIV or HCV. (Information that applies to all transfusion services laboratories is highlighted.)