BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay 의 안전성 경고

Safety alert

2014-11-14

2014-11-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141114a.html

Medical device safety alert: bd probetec chlamydia trachomatis (ct) qx assay and the bd probetec neisseria gonorrhoeae (gc) qx assay medical device manufacturer, bd, has issued a field correction action concerning the bd probetec chlamydia trachomatis (ct) qx assay with catalogue number 442959 and the bd probetec neisseria gonorrhoeae (gc) qx assay with catalogue number 442842. the manufacturer has learned that some customers performing the bd probetec chlamydia trachomatis (ct) qx assay and the bd probetec neisseria gonorrhoeae (gc) qx assay with the viper lt instrument are experiencing a higher than expected rate of positive test results (i.E., increased prevalence). this observation is limited to a subset of test results obtained from specimens yielding “max rfu” values in the approximate range of 125 to 250. this includes occasionally obtaining positive results for the assay negative control. based on internal investigations to date, the manufacturer has confirmed that this change in test performance is attributable to an increase in false positive results. the anomaly only impacts ct/gc assay results on the viper lt. the manufacturer will provide affected users with alternative testing methods until the issue of false positive results is addressed. the manufacturer’s representatives will contact users directly to determine which methods/options would be the most viable to satisfy their testing needs. the interim solutions include testing on an alternate platform (viper xtr, probetec, or a competitor’s instrument) or sending the ct/gc testing out to alternate laboratories. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 november 2014.