Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01002-1
Product Name/Description	VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD) Reference Number: 30318 Lot Number: 1002903980
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	16/09/2014
Responsible Entity	Biomerieux Australia Pty Ltd
Reason/Issue	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”.
Recall Action	Recall for Product Correction
Recall Action Instructions	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.
Contact Information	1800 333 421 - bioMerieux Technical Assistance Department