This is reportable to the FDA. This issue is not purity, etc, but the ability to track a product years from now if there is a lookback, recall or market withdrawal. The code is QC-97-19 The best way to get an idea of what is and is not reportable, is to look at the coding scheme. Obviously a lot are collection related issues, but not exclusively. If your crossmatch tags that are attached to the product are wrong, or you send out the wrong product, or patient. here's the link to the coding http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129721.htm and the specifics for the failure to electronically release that is under QC and distribution: QC-97-19 Product not documented or incorrectly documented as issued in the computer (computer documentation is final check of issue process)