Alerta De Seguridad para VIDAS CA 15-3

Safety alert

2018-07-18

2018-07-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180718a.html

Medical device safety alert: biomerieux vidas ca 15-3 medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its vidas ca 15-3 [reference: 30429; lot number: 1006022590 and 1006251930]. following customers’ complaints for calibrations out of range (standard s1 out of range low and/or control c1 out of range high) when using the affected lots, investigators confirmed a defect on the identified products and reproduced the issue reported by the customers. the manufacturer has identified that s1 signal decrease was probably due to a particular lot of raw material (bovine albumin) which is a component of standard s1, which was not performing as expected. the lot of raw material was not used for the manufacturing of any other product. it has been established that standard s1 will continue to decrease over time, what will lead both lots of finished products to be unusable due to invalid calibrations. investigators showed that control c1 is conforming expected specifications. its relative fluorescence value (rfv) does not evolve overtime. the c1 out of range high reported by some customers is not linked to a signal increase but is due to standard s1 decrease. according to the manufacturer, as the vidas systems trigger an alarm in case of invalid calibration, the defect is easily identified. the identified issue can lead to delayed results. there is no risk for false results. the defect (standard s1 signal decrease) can have two impacts on the finished product: standard s1 is obtained out of range low at the opening of the kit: the kit cannot be calibrated and cannot be used, what leads to delayed results. control c1 is obtained out of range high at the time of the recalibration: the kit cannot be calibrated and cannot be used, what leads to delayed results. affected users are instructed to destroy the impacted lots. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 18 july 2018.