Catalog Number 10376324 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens has requested more information and to see if the customer is able to send back any materials for investigation.Investigation will commence once the requested data has been received.The cause of this event is unknown.
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Event Description
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The customer reported that they received a false negative leukocyte result on their clinitek status+ instrument compared to retesting on their laboratory instrument.There is no report of injury due to this event.
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Manufacturer Narrative
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The customer stated that the reagent is not available for return, therefore an investigation cannot be performed.Siemens has reviewed the certificate of analysis for the reagent lot in use at the time of the event and the product met and passed all specifications upon manufacturing release.The cause of this event is unknown.
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Search Alerts/Recalls
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