Lot Number COV3090005 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/20/2023 |
Event Type
malfunction
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Event Description
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Invalid result (s).The customer stated that the kit they bought from cvs did not produce a control (c) or test (t) line.
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Manufacturer Narrative
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The current complaint is pending investigation from our contract manufacturer, and we will provide follow up mdr upon investigation completion such as review of batch records or testing of retention samples.Any additional information received by acon may be provided to fda in a follow up mdr.
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Manufacturer Narrative
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Final product manufacture and qc record for cov3090005.No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.The test results of retention samples from cov3090005 can meet the qc criteria.We have not found the complaint issue from the retained cassettes.The complaint is not verified.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.
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Event Description
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Invalid result (s).The customer stated that the kit they bought from cvs did not produce a control (c) or test (t) line.
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Search Alerts/Recalls
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