Catalog Number 442021 |
Device Problem
False Positive Result (1227)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic), there was a molecular false positive.No patient impact reported.The following information was provided by the initial reporter: "customer reporting molecular false positive for product 442021 lot number 3102666.".
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Manufacturer Narrative
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H.3.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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Catalog: 442021.Batch no.: 3102666.Customer reported a molecular false positive result.Neither photos nor returned good samples were received.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted, and batch has been previously investigated for the reported defect.Complaint is unconfirmed based on retention samples and batch history record review results.
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Event Description
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It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic), there was a molecular false positive.No patient impact reported.The following information was provided by the initial reporter: "customer reporting molecular false positive for product 442021 lot number 3102666.".
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Search Alerts/Recalls
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