Model Number 800-20202-08 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/25/2018 |
Event Type
malfunction
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Event Description
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The customer reported a possible discrepancy.The donor is c+ and e+ using the bioarray hea molecular beadchip kit; serology results were c- and e-.
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Manufacturer Narrative
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Bioarray received request from fda mdr team to resubmit this follow-up report due to error in reporting back in 2018.
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Event Description
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The customer reported a possible discrepancy.The donor is c+ and e+ using the bioarray hea molecular beadchip kit; serology results were c- and e-.
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Search Alerts/Recalls
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