Catalog Number 06368921190 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Country of origin is (b)(6).Sample from the patient was requested for the investigation.A calibration was performed by the customer and passed.
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Event Description
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The initial reporter received questionable elecsys anti-hcv immunoassay results from the cobas e411 disk analyzer serial number (b)(4).The initial result was 0.077 coi (non-reactive.) the result by a reference qualitative manual method was positive for antibodies to hcv.The result by western blot manual confirmation was positive for defined antibody type to hcv.The result by pcr: hcv rna was not detected.No questionable results were reported outside the laboratory.
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Manufacturer Narrative
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A sample was returned for investigation, and was tested with retention materials.The customer¿s negative elecsys anti-hcv result was reproducible.The sample was blot tested and the result was indeterminate.The anti-hcv reagent performed within specification.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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