Blood & biologics.12450W Antelope Valley Healthcare District, Lancaster, CA, May 1 (Los Angeles). FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. found that a donor at Antelope Valley who tested reactive to anti-HIV-1/2, and who had an indeterminate licensed HIV-1 Western Blot Western blot A technique developed in 1979 that is used to confirm ELISA results. HIV antigen is purified by electrophoresis and attached by blotting to a nylon or nitrocellulose filter. result in 1994, was inappropriately re-entered as a suitable donor in 2002. In addition, the letter stated that two whole blood units were subsequently collected from this individual and the red cell components transfused. The agency faulted the establishment's SOPs for failing to include a written description of all steps of donor suitability and the donor deferral donor deferral Transfusion medicine The nonacceptance of a potential donor based on lifestyle criteria or prior exposures to pathogens. See Donor exclusion criteria. process, and noted Antelope Valley's failure to maintain a record from which unsuitable donors may be identified. Additionally, the agency stated that the equipment Antelope Valley had used in collecting blood was not calibrated cal·i·brate tr.v. cal·i·brat·ed, cal·i·brat·ing, cal·i·brates 1. To check, adjust, or determine by comparison with a standard (the graduations of a quantitative measuring instrument): on a regularly scheduled basis. An unnamed investigator inspected the blood bank Dec. 17-18, 20, 26-27, 2002, and January 2. Cal, QC/QS |
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