SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS CENTAUR XP / SIEMENS SARS COV2T ANTIBODY TEST; REAGENT, CORONAVIRUS SEROLOGICAL
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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 12/10/2020 |
Event Type
malfunction
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Event Description
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Discrepant covid antibody test result, result = 1.28 positive, rerun =.60 negative reported to siemens ref# (b)(4).Siemens lot # 95041007.Fda safety report id# (b)(4).
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