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Model Number AS480 |
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 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Root cause: alteration of staining in this case was due to leak or loose fitting in tubing & connections.The problem was solved by field service engineer with repair of the part.Following the repair, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a tubing or connection malfunction; the resulting failure modes could occur.Leak from probe or drip from z-head could impact aspiration/dispense.These failure modes have the potential to alter staining.
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Event Description
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Based on complaint report or investigated failure mode, there was a staining alteration.Customer complaint record reported the event as follows: intermittent false negative slides.No direct or indirect patient harm or user harm has been reported.
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Search Alerts/Recalls
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