Section 211.150 requires that the manufacturer be able to trace the lot number of the 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.)
(19) Procedures under 610.46 and 610.47 of this chapter:
11(i) To identify previously donated blood and blood components from a donor who later tests reactive for evidence of human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection when tested under 610.40 of this chapter, or when a blood establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection;
(ii) To quarantine in-date blood and blood components previously donated by such a donor that are intended for use in another person or further manufacture into injectable products, except pooled components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures;
(iii) To notify consignees to quarantine in-date blood and blood components previously donated by such a donor intended for use in another person or for further manufacture into injectable products, except pooled components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures;
(iv) To determine the suitability for release, destruction, or relabeling of quarantined in-date blood and blood components;
(v) To notify consignees of the results of the HIV or HCV testing performed on the donors of such blood and blood components;
(vi) To notify the transfusion recipient, the recipient's physician of record, or the recipient's legal representative that the recipient received blood or blood components at increased risk of transmitting HIV or HCV, respectively.
