Catalog Number 04906969001 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The test strip lot number and expiration date were requested, but not provided.The investigation is ongoing.
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Event Description
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The initial reporter stated they received questionable results for an unspecified number of patient samples tested on a cobas u 411 urine analyzer.Multiple test parameters are affected.The customer provided an example of one patient sample with discrepant leukocyte values.The sample initially resulted in a leukocyte value of 500 leukocytes/ul.The same sample was repeated, resulting in a negative leukocyte value.
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Manufacturer Narrative
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The quality controls failed.The field service engineer replaced the photometer and the instrument was working properly after this action.The investigation determined the service actions resolved the issue.
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Search Alerts/Recalls
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