SIEMENS HEALTHINEERS / SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS CENTAUR XP; REAGENT, CORONAVIRUS SEROLOGICAL
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Model Number CENTAUR XP |
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 10/27/2020 |
Event Type
malfunction
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Event Description
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Discrepant covid antibody test result, result = 1.15, (positive) rerun =.47 (negative).Fda safety report id# (b)(4).
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Search Alerts/Recalls
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