(2) You must perform further testing for HIV as required under § 610.40(e) of this chapter on the reactive donation.
(B) Notify consignees to quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section if intended for use in another person or for further manufacture into injectable products, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures (A) Quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section if intended for use in another person or for further manufacture into injectable products, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures and (ii) Twelve months and less before the donor's reactive direct viral detection test, e.g., nucleic acid test or HIV p24 antigen test, and nonreactive antibody screening test, whichever is the lesser period, you must: (i) Twelve months and less before the donor's most recent nonreactive screening tests, or
For those identified blood and blood components collected: (1) Within 3 calendar days after a donor tests reactive for evidence of human immunodeficiency virus (HIV) infection when tested under § 610.40(a) and (b) or when you are made aware of other reliable test results or information indicating evidence of HIV infection, you must review all records required under § 606.160(d) of this chapter, to identify blood and blood components previously donated by such a donor. (a) If you are an establishment that collects Whole Blood or blood components, including Source Plasma and Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions: 610.46 Human immunodeficiency virus (HIV) "lookback" requirements.
Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections PART 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS
#Code of va 46.2 838 code
The information on this page is current as of Oct 01, 2021.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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