VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD) 의 리콜

Recall

RC-2014-RN-01002-1

Class III

2014-09-16

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01002-1

The information referenced in the current ifu is incorrect with regards to specimen stability for samples in stoppered tubes. in the instruction for use (ifu), the paragraph “specimen stability” states, “the stability of the sample separated from the clot has been validated using samples in stoppered tubes: at 18-25°c for 3 days”. further review identified that the data of the stability study mentioned in the product review development report file (ref. vr11) is “for stoppered tubes, at 18-25°c for 8 hours”. the instructions for use should state: “the stability of the sample separated from the clot has been validated using samples in stoppered tubes at 18-25°c for 8 hours”.

BioMerieux is notifying their customers that the IFU incorrectly states that sample is stable for 3 days at 18-25 degrees C once separated from the clot. The correct stability is 18-25 degrees C for 8 hours. This action has been closed-out on 01/03/2016.