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Model Number TN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The field service engineer (fse) was on site and confirmed what the customer reported.To resolve the issue the fse replaced the tarpon amp boards at the affected locations (ss/fl3/fl4/fl5).Bec is filing an mdr for this event based on the fda classification of the 08 jan 2018 urgent medical device recall as a class i recall on 20 nov 2018 (recall number z-0471-2019 for fc 500; recall number z-0472-2019 for epics xl/xlmcl).Bec internal identifier: (b)(4).
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Event Description
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The customer reported amp board errors at the side scatter (ss), fl3, fl4, and fl5 positions on their fc 500 flow cytometer.There was no report of death, injury, or change to patient treatment as a result of this event.
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Search Alerts/Recalls
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