Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor 의 안전성 경고

Safety alert

2017-05-15

2017-05-15

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170515a.html

Medical device safety alert: beckman coulter access total t3, access thyroglobulin, access free t4, access gi monitor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its access total t3, access thyroglobulin, access free t4, access gi monitor [reference numbers: 3380 (total t3), 33860 (thyroglobulin), 33880 (free t4), 387687 (gi monitor); lot numbers: all] for use with the access family of immunoassay systems. the manufacturer has determined through customer feedback and internal investigation that the four access immunoassays listed above are susceptible to biotin interference. during interference testing the interference occurred with samples that contained 100 ng/ml of biotin. this level of biotin is greater than the maximum biotin concentration observed in the normal healthy population. according to the manufacturer, specimens from patients who are undergoing biotin therapy and/or ingesting biotin supplements may contain high levels of biotin. the higher biotin concentration in these specimens interferes with the biotin-streptavidin assay design of the four access assays listed previously. other access assays with a biotin-streptavidin assay design were also tested. these assays are not affected by higher biotin concentrations. specimens that contain high levels of biotin may cause: false low results for the access gi monitor and thyroglobulin assays. false high results for the access free t4 and total t3 assays. the customers are advised to take following actions: interpret results in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. a retrospective review of results is not recommended. the manufacturer will update the limitations section of the access total t3, thyroglobulin, free t4, and gi monitor instructions for use with this biotin interference information. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2017.