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 12/12/2022 |
Event Type
malfunction
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Event Description
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The field service engineer (fse) reported signal shift at fl2 and fl3 positions on the fc500 flow cytometer while running flow check control while servicing the instrument.There was no report of death, injury, or change to patient treatment as a result of this event.There were no erroneous patient results generated.
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Manufacturer Narrative
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Patient information is not applicable.There was no impact to patients as a result of this event.While the fse was servicing the instrument for an unrelated issue, he observed that the tarpon xl amp assembly at the fluorescence channel (fl2 and fl3) positions was defective.To resolve the issue the fse replaced the board at the identified positions.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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Manufacturer Narrative
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Follow up report 01- correction field g3 date received by manufacturer revised to reflect correct date of awareness by bec.Bec internal identified - (b)(4).
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Search Alerts/Recalls
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