VIDAS D-Dimer Exclusion II 의 안전성 경고

Safety alert

2013-01-23

2013-01-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130123a.html

Medical device safety alert: biomérieux vidas d-dimer exclusion ii health canada has posted a medical device safety alert concerning vidas d-dimer exclusion ii manufactured by biomérieux. the affected model/catalogue and lot/serial numbers are 30455 and 1001399220 respectively. the manufacturer has registered two complaints on false negative results under the detection limit (<45 ng/ml) using the batch 1001399220. the investigation indicates that there is the potential for a manufacturing issue to be the cause of the problem and root cause investigations are in-process. the impact of a false negative d-dimer test result could be critical for the patient because it could prevent further diagnostic workup for venous thromboembolism and withhold anticoagulant treatment when it is actually needed, resulting in a negative impact to patient care. as a preventive measure, biomérieux has decided to remove the suspect product from the field. furthermore, all affected users are advised to take the following necessary actions: stop using and destroy the affected products. perform a retrospective analysis of the patients tested on this batch and investigate further (e.G. final diagnosis and clinical status of the patient) if the result is < 45 ng/ml. according to the local supplier, the affected products are distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_jan-mar_2013-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 23 january 2013.