A review of complaints found no trends or similar issues for the complaint issue.Manufacturing documentation for the reagent lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the biological and chemical safety hazards that may exist.The architect hiv ag/ab package insert states that this product contains human sourced and/or potentially infectious components and should be considered potentially infectious.It is recommended that these reagents and human specimens be handled in accordance with the osha standard on bloodborne pathogens.In addition, the safety data sheet (sds) for the architect hiv ag/ab states that if the material comes in contact with the eye to rinse cautiously with water for several minutes.If eye irritation persists, get medical advice/attention.Wear safety glasses or other protective eyewear.If splash potential exists, wear full face shield or goggles.The sds documents that there is no irritant effect to eyes by the reagent.Since the user was not wearing eye protection as required per the safety instructions as outlined in the architect hiv ag/ab package insert and the safety data sheet (sds) use error contributed to the incident.Based on our investigation no product deficiency was identified for the architect (b)(6) reagent, list number 02p36.Section a patient information: no specific patient/user information was provided.
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