Test Cells for Red Cell Antibody Screening 의 안전성 경고

Safety alert

2017-02-14

2017-02-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170214.html

Medical device safety alert: diamed test cells for red cell antibody screening medical device manufacturer, diamed, has issued a field safety notice concerning its test cells for red cell antibody screening. the product names (catalogue numbers) of the affected devices are as below: id-dia (diego) positive (004134); id-diacell sf (003640); id-diacell pool (003630 / 003631); id-diacell abo/i-ii (003610); id-diacell abo/i-ii-iii (003618); id-diascreen i-ii-iii-iv-vp-vip (004316); id-diacell i-ii (003613); id-diapanel (004114); id-diacell i-ii-iii (004310); id-diascreen i-ii-iii-iv (004311); id-diacell i-ii-iii asia (003614); id-diascreen prophylax (004330); id-diapanel plus 6 (004414); id-diacell i-ii (003613vj); id-diapanel (1-11) (004114vj ); id-dia positiv (004134vj); id-diacell i-ii-iii (004310vj) the manufacturer has identified unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the above mentioned products. this phenomenon is observed randomly between batches, and also within single batches. according to the manufacturer, a risk assessment has been done, and the conclusion is that this unexpected result requires further confirmation testing before a final transfusion decision is made. negative results can be reliably accepted as negative. the manufacturer advises affected users of the following:- in case of doubtful reactions, re-test with a new kit. if the results remain in doubt, send the sample to a reference laboratory and if an urgent transfusion is required, perform a crossmatch. 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 14 february 2017.