EP26IG
User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide, 1st Edition
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User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide, 1st Edition
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify that new reagent lots, when received and implemented by the laboratory, will produce results consistent with previous reagent lots. Reagent lot performance is validated by the developer before release and distribution; however, the laboratory needs to verify each new reagent lot it receives.
This document is available in electronic format only.
