Day

April 5, 1996
Abaxis 4/5/96 blood analyzer 1. Failure to validate computer software programs by adequately documented testing, when computers are used as part of an automated production or quality assurance system (21 CFR 820.61). The computer programs which control the automated assembly of rotor parts, loading of reagent beads, dispensing of reagent beads into proper cuvettes, and...
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