Catalog Number 251275 |
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 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using plate mueller hinton ii agar contamination occurred.The following information was provided by the initial reporter: "the customer found that the media was contaminated.".
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Event Description
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It was reported that while using plate mueller hinton ii agar contamination occurred.The following information was provided by the initial reporter: "the customer found that the media was contaminated.".
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Manufacturer Narrative
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H.6 investigation summary: 251275 #2200275.We couldn't confirm this issue as a report because no photo and returned sample.Complaint history was reviewed, and no other complaint has been taken on this lot.At this time.Device history record review (dhr), did not indicate any discrepancies.All release testing was satisfactory and no deviations were observed.It includes bioburden testing.A visual inspection was performed on 20 retention samples of this lot.As a result, no contamination was observed.The root cause for this could not be determined.
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Search Alerts/Recalls
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