Model Number 298330 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2021 |
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 bd bbl¿ rapid urea broth false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer reports increased positivity that is discrepant with pathology biopsy results with use of media item 298330-bbl rapid urea broth.".
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Event Description
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It was reported that while using bd bbl¿ rapid urea broth false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer reports increased positivity that is discrepant with pathology biopsy results with use of media item 298330-bbl rapid urea broth.".
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Manufacturer Narrative
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H.6.Investigation: material 298330 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The solution is then sterile filtered and dispensed into tubes.The tubes are manually the batch history record review for batch 1072858 was satisfactory at time of release and no notifications were generated during manufacturing and inspection.Filling, torquing, and packaging processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 1072858 (10 vials) were available for inspection.No contamination visual defects were observed in the retention samples.Retentions were performance tested per procedure.Performance testing of the retentions was satisfactory.
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Search Alerts/Recalls
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