FilmArray Blood Culture Identification Panel used with Becton Dickinson BACTEC Blood Culture Bottle 의 안전성 경고

Safety alert

2018-03-23

2018-03-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180323.html

Medical device safety alert: filmarray blood culture identification panel used with becton dickinson bactec blood culture bottle medical device manufacturer, biofire diagnostics (biofire), has issued a medical device safety alert concerning its filmarray blood culture identification (bcid) panel used with becton dickinson (bd) bactec blood culture bottle [bd blood culture bottle catalog numbers: 442020, 442021, 442023, 442192 and 442265; expiration dates: 30 september 2018 and 31 october 2018]. biofire has identified an increased risk of false positive proteus results when the filmarray bcid panel is used with the affected bd bactec blood culture bottles. biofire has confirmed the presence of proteus nucleic acid in several of the lots of affected media using an independent pcr/bi-directional sequencing method. the presence of non-viable organism does not compromise the intended function of the blood culture bottles (culturing viable microorganisms). however, the filmarray bcid panel detects nucleic acid from viable and non-viable organisms alike. observed false positives are typically seen as multiple positives with the filmarray bcid panel because a positive culture is a prerequisite to a bcid test. according to biofire, the filmarray bcid panel product literature includes the following limitations: blood culture media may contain non-viable organisms and/or nucleic acid at levels that can be detected by the filmarray bcid panel leading to false positive test results. typically, these false positives will be present with more than one positive result because the bcid panel will also detect the organism that is growing in the culture bottle. in rare cases, the gram stain result and results of the filmarray bcid panel may be discrepant. in these cases, the results should be used in conjunction with other clinical and laboratory findings. the affected users are advised to the following action: if the filmarray bcid panel is used to test bd bactec blood culture bottles with expiration dates of 30 september 2018 or later, positive results for proteus should be confirmed by another method prior to reporting the test results. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 march 2018.