VIDAS TOXO Competition Kit 의 안전성 경고

Safety alert

2016-08-10

2016-08-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_201608010.html

Medical device safety alert: biomerieux vidas toxo competition kit medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its vidas toxo competition kit [reference number: 30211; lot number: 1004666050; expiration date: 24 jan 2017]. the manufacturer received several complaints due to c2 control out of range on the affected product. due to this anomaly when the calibration is launched an alarm is triggered by the instrument. however, this alarm does not block the run and results are still provided. the investigation is on progress; however, the manufacturer has already highlighted that: the anomaly occurs randomly on certain kits of the impacted lot 1004666050, this result is linked to an increase of s1 standard’s rfv (relative fluorescence value) signal. considering the rfv signal increase of s1 standard, involving c2 control rfv signal decrease, the most probable hypothesis is the rfv signals will continue to evolve what could lead to block the calibration. according to the manufacturer, one positive control and one negative control are included in each vidas txc kit. these controls must be performed immediately after opening a new kit to ensure that reagent performance has not been altered. each calibration must also be checked using these controls. the instrument will only be able to check the control values if they are identified by c1 and c2. results cannot be validated if the control values deviate from the expected values. the expected negative control value must be included in the range indicated on the mle card. as the results cannot be validated there is no potential for false result. the potential hazard is to have delayed results. the manufacturer is advising users to discontinue use and discard any remaining inventory of the affected lot. 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 10 august 2016.