A review of the complaint text showed that the user injury is related to user error, since the user did not wear safety glasses when the issue occurred.The tracking and trending review determined that there are no trends identified for the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Since the issue occurred by use error and is not related to the performance of the product, no file kit testing is required.A review of labeling concluded that the issue is adequately addressed.Additionally, the following is provided in the safety data sheet for the architect syphilis tp negative control 3 (ln 8d06-13; component 8d06l), section 8.2 exposure controls: eye protection - wear safety glasses or other protective eyewear.If splash potential exists, wear full face shield or goggles.Based on the investigation, we have determined that there is no issue with the architect syphilis tp negative control, use error may have contributed to the customer's issue.
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