Dhr reviews were performed including an assessement of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were observed.The dhr indicated that the released product met all specifications.During the field service support follow-up visit, the nova biomedical technician discovered that the reference cartridge was not seated.The technician reseated the reference sensor and primed the fluids.The instrument was calibrated four (4) times and controls were analyzed.The customer reported the reference pump tubing was being pulled tightly through the pump due to a detached retaining collar.However, it was determined that the reference pump tubing did not contribute to the discrepant results, based on the fact that other reference dependent results were normal.Testing of a retained sensor card from the same lot met the acceptance criteria and no erroneous results were observed.
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