Notes regarding above "unknown" responses: patient information: unknown.Biocare medical reached out to the (b)(4) distributor on 03/17/2020,03/21/2020, 04/01/2020, 04/17/2020, and 04/22/2020.The distributor provided very limited data to allow successful evaluation.In addition, on 04/26/2020, distributor indicated the pathologist and hospital would like to drop the case.Hence no additional technical and regulatory details could be obtained.Adverse event or product problem: due to limited information, biocare medical cannot provide date of adverse event, relevant tests/laboratory date, and patient's preexisting medical conditions for reporting.Suspect products: mr.(b)(6) only provided product name and catalog number; however lot number was not provided to biocare medical.Therefore, this information is unknown.Biocare medical reached out to the (b)(4) distributor on 03/17/2020,03/21/2020, 04/01/2020, 04/17/2020, and 04/22/2020.The distributor provided very limited data to allow successful evaluation.In addition, on 04/26/2020, distributor indicated the pathologist and hospital would like to drop the case.Hence no additional technical and regulatory details could be obtained.Not applicable.Suspect medical device: lot number and expiration date are unknown to date due to limited information from mr.(b)(6).Device manufacturers only: biocare medical did not initiate a remedial action due to limited information provided by mr (b)(6).In addition, biocare medical did not receive additional complaints related to adverse event from its customers who also purchased this antibody.As part of due diligence, biocare medical also performed technical review of the original design testing and product surveillance data.Upon review, with almost twelve years of historic data, biocare medical feels confident in this product and see no justification for withdrawal from the market.
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