ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
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Lot Number COV3030009 |
Device Problem
False Positive Result (1227)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/28/2024 |
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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False positive result (s).Customer reported the following, "i took a flowflex antigen home test.It was positive.I went to urgent care and got a pcr (polymerase chain reaction) rvs.Both were negative.They asked me to do another at home and i did and it was positive.I did another pcr on wed.Neg.Thurs.Binaxnow neg.Friday binaxnow neg.I'm so glad i did not take the paxlovid.I have a bacterial infection.My boxes of flowflex say expire 2025, date (2) 3/27, one 3/26 on 1.Your website says 2024 for cov3030007 ov3030007 expire this month.This was a false positive i believe because the close expiration date being 2024 not 2025." mdr# mw5151804/mw5151805.
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Event Description
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False positive result (s).Customer reported the following, "i took a flowflex antigen home test.It was positive.I went to urgent care and got a pcr (polymerase chain reaction) rvs.Both were negative.They asked me to do another at home and i did and it was positive.I did another pcr on wed.Neg.Thurs.Binaxnow neg.Friday binaxnow neg.I'm so glad i did not take the paxlovid.I have a bacterial infection.My boxes of flowflex say expire 2025, date (2) 3/27, one 3/26 on 1.Your website says 2024 for cov3030007 ov3030007 expire this month.This was a false positive i believe because the close expiration date being 2024 not 2025." mdr# mw5151804/mw5151805.
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Manufacturer Narrative
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Batch records for final product manufacture and qc record for cov3030009 were reviewed and 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 cov3030009 met the qc criteria.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.The following fields are updated: b4, "date of this report" - date of follow-up report.G6, "type of report" - follow-up #1.H2, "if follow-up, what type?" - updated to "additional information" and "device evaluation".H6 "adverse event problem" - event problem and evaluation codes such as "investigation.Findings" and "investigation.Conclusions" are added per investigation.H10 "additional narrative/data" - added manufacturer's narrative.
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Search Alerts/Recalls
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