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 monitoring and inspecting by optical sensors have not been validated.

FDA does not accept the response by Abaxis to this item. The testing done only determined if the manufacturing equipment would shut down if the wrong components were used. No information on the calibration of the manufacturing equipment was provided.