GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ GBS; NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN
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Catalog Number 441772 |
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 03/20/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D2.Additional medical device type: ooi.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that during use with the bd max¿ gbs assay, there was a false positive result.There was no report of patient impact.Report 3 of 5.
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Manufacturer Narrative
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H.6 investigation summary the complaint investigation for discrepant results when using the bd max gbs (ref 441772) lot 3291340 was performed by the review of manufacturing records and by the complaint¿s history review.Customer complained about a negative qc control testing as positive when using the bd max gbs lot 3291340.The run contained 7 samples (5 patients; 1 negative control; 1 positive control) and all turned out positive.Review of the manufacturing records of the bd max gbs lot 3291340 indicated that the lot was manufactured according to specifications and met performance requirements.Despite multiple attempts made to receive information from the customer, no data was provided for the investigation.Without data, bd is unable to identify the cause of the customer issue.The root cause was not identified.However, environmental contamination or sample cross-contamination could explain the customer¿s discrepant results.Detailed instructions for extended environmental run and cleaning steps were provided to the customer.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant on bd max gbs lot 3291340.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and a preventive action plan since no new hazard or trends was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.
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Event Description
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It was reported that during use with the bd max¿ gbs assay, there was a false positive result.There was no report of patient impact.Report 3 of 5.
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Search Alerts/Recalls
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