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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 11/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Root cause: potential alteration of staining in this case was due to improper operation of the syringe and stopcock.The problem was solved by field service engineer with replacement of the part.Following the replacement, the instrument was fully operational within specifications, without errors, and available for the user.Failure mode description: following a syringe and stopcock malfunction or if the part stops working; the resulting failure modes could occur.Drip diluting reagents on slide, or probe leak altering 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: uneven staining no direct, or indirect patient harm, or user harm have been reported.
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Search Alerts/Recalls
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