Premier Buffer B Reagent 의 안전성 경고

Safety alert

2017-06-07

2017-06-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170607a.html

Medical device safety alert: trinity biotech premier buffer b reagent medical device manufacturer, trinity biotech, has issued a medical device safety alert concerning its premier buffer b reagent [product code: 01-03-0096 (940 ml); lot number: 6524]. the manufacturer has identified that the closed bottle stability for some bottles of lot 6524 may be reduced due to a broken seal under the cap of unopened bottles. in cases where a broken seal of an unopened bottle is encountered, the open bottle stability is essentially started and the bottle stability performance will be reduced, as it would over time when installed on the premier hb9210 system. where analytical run qc recovery is within range, the performance of the system and results are acceptable. however, if an unopened reagent bottle is found to have a broken seal prior to use, the open bottle stability has started. prior to consumption of the bottle, it may be observed that controls drift out quicker than normal, thereby requiring more frequent calibrations. the qc recovery (controls) verification will identify and contain this issue, as designed and there is no need for review of previously reported results. a thorough investigation into the root cause has been conducted and no other lots are affected. to avoid need for extra control runs and calibrations, the manufacturer recommends: discontinue the use of the above reagent lots. destroy any remaining product. notify all end-users of this notification. product replacement is on-going. 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 7 june 2017.