Lot Number COV3090006 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/14/2024 |
Event Type
malfunction
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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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Event Description
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Invalid result (s).Invalid result.The customer stated that their cassette did not produce a result.The customer confirmed that at least 4 drops were added into the sample well.
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Event Description
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Invalid result (s).Invalid result.The customer stated that their cassette did not produce a result.The customer confirmed that at least 4 drops were added into the sample well.
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Manufacturer Narrative
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Batch records for final product manufacture and qc record for cov3090006 were reviewed.No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.Retention samples from cov3090006 were tested and met the qc criteria.The issue was not found from the retained cassettes.The complaint could not be verified.
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Search Alerts/Recalls
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