BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHOCOLATE II AGAR (GC II AGAR WITH HEMOGLOBIN AND ISOVITALEX¿); CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
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Model Number 221267 |
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 10/03/2022 |
Event Type
malfunction
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Event Description
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It was reported that bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿) had atypical colony morphologies growing on product.No patient impact was reported.The following information was provided by the initial reporter: customer is reporting atypical colony morphologies growing on product 221267, lot 2206461.
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Manufacturer Narrative
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Device evaluated by mfr: 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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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
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Search Alerts/Recalls
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