CALEX Cap Device 의 안전성 경고

Safety alert

2017-03-20

2017-03-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170320b.html

Medical device safety alert: bühlmann laboratories ag calex cap device bühlmann laboratories ag has issued a medical device safety alert concerning its calex cap device [catalogue number: b-calex-c50, b-calex-c200, b-calex-c500]. according to the manufacturer, a mean positive bias of 15.6 % has been confirmed for results obtained with stool extraction using the original calex cap device in comparison to results obtained with the reference manual weighing and extraction method – 1:50 dilution. given the overall analytical and clinical performance of fecal calprotectin assays and the general imprecision level of stool extraction methods, the above mean bias of 15.6 % is considered to have limited impact on result interpretation. the positive bias may, in few cases, lead or have led to the interpretation of calprotectin levels as elevated (> 200 μg/g), requiring further investigative and curative procedures. with stool specimen preparation using the reference manual extraction procedure, they would be determined as having a low inflammatory response thus repeating the measurement and performing further investigations would be recommended. in few cases patients may be or may have been assigned as having a low inflammatory response (> 50μg/g), although, with stool specimen preparation using the reference manual extraction procedure, they would be determined as having normal calprotectin values. affected users are advised to the take the following actions:- when reviewing current calprotectin results obtained for stool specimens extracted with the original calex cap device (calex lots without “n”), consider the positive bias described above. a fast transition to the calex cap “n” device with high method agreement with the manual weighing and extraction – 1:50 dilution method is recommended. 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 20 march 2017.