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:
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