Model Number C2020 |
Device Problem
False Negative Result (1225)
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Patient Problems
Malaise (2359); Sore Throat (2396)
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Event Date 07/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Explanation for device evaluated by manufacturer: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false positive tests and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were no previous similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.A technical support representative reviewed customer data and performed data analysis.All data values were normal and met acceptable criteria.Root cause was undetermined.
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Event Description
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On (b)(6) 2022, customer reported a potential false negative cue result with cartridge sn (b)(4) lot 23106e and reader (b)(4).Customer followed up with a binax antigen test on the same day and received a positive result.Customer had body aches, sniffles, and a sore throat.Customer confirmed the cartridges were stored within the recommended temperature range even though california temperature were hot.
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Manufacturer Narrative
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Update to g4: pma/510(k) number added update to h10: additional information regarding investigation added technical operations performed retain testing and was unable to confirm the customer complaint.No false negative results were observed.Correction to h10: update "false positive" to "false negative" explanation for h3: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false negative tests and a member of the technical support group was able to perform data analysis.
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Search Alerts/Recalls
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