Catalog Number 256089 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that 2 boxes of bd rapid detection of sars-cov-2 veritor¿ had the cartridge for a bd veritor flu a+b testing system.Eua # (b)(4).The following information was provided by the initial reporter: lab-tech informed that they found an unusual bd veritor flu a+b device cartridge (just one piece from each dungeon) instead of the usual bd veritor¿ system sars-cov-2 device cartridge when taking out from the bd kit box.
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Manufacturer Narrative
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Eua # (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that 2 boxes of bd rapid detection of sars-cov-2 veritor¿ had the cartridge for a bd veritor flu a+b testing system.Eua # (b)(4).The following information was provided by the initial reporter: lab-tech informed that they found an unusual bd veritor flu a+b device cartridge (just one piece from each dungeon) instead of the usual bd veritor¿ system sars-cov-2 device cartridge when taking out from the bd kit box.
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Manufacturer Narrative
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H6: investigation summary this statement is to summarize the investigation results regarding your complaint that alleges finding one bd veritor flu a+b device cartridge when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number 1188402.Bd quality performs a systematic approach to investigate a product mix up.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation including reviewing all returned photographs were performed and concluded that the flu test was introduced during the pouching process of the sars kit.A capa 4148219 was opened to address this issue.The complaint was confirmed.Bd quality will continue to closely monitor for trends.
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Search Alerts/Recalls
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