It was reported that prior to using bd veritor¿ system for rapid detection of rsv - laboratory kit, there were missing labels.No patient impact reported.The following information was provided by the initial reporter: "customer reports that labels are missing and they are unable to determine lot #s customer clarified that the issue is that the plastic bag in the photo is kit contents that came without a box, so they are unable to determine the lot # of the kit.".
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It was reported that prior to using bd veritor¿ system for rapid detection of rsv - laboratory kit, there were missing labels.No patient impact reported.The following information was provided by the initial reporter: "customer reports that labels are missing and they are unable to determine lot #s customer clarified that the issue is that the plastic bag in the photo is kit contents that came without a box, so they are unable to determine the lot # of the kit.".
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H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that involved kit rsv 30 test hospital veritor (material # 256042, batch number unknown.The customer reported missing labels with rsv kit, and they could not provide the lot number.While inquiring, they clarified that the kit contents came without a box, so they were unable to determine the lot # of the kit.Bd quality performs a systematic approach to investigate labeling / packaging issue complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing could not be performed because a batch number was not provided.No physical samples were returned; therefore, return sample analysis could not be conducted.However, the customer provided the photographs, which showed rsv kit contents were packed in a plastic cover without box.This complaint was confirmed based on the photographic evidence.The root cause could not be identified.Currently, there are no adverse trends identified for labeling / packaging issue.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.
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