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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00096-1
Product Name/Description VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).

Bacteria identification and sensitivity system
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/02/2015
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue bioMeriuex has identified that the inoculum density range for the Neisseria Haemophilus (NH) Identification (ID) Test Card in the VITEK 2 7.01 Product Information document (Ref: 514740-1EN1) is incorrect. In Section 6 - Procedure For NH Card Specimen Preparation (step 3), the documented DensiCHEK Plus inoculum density range is 1.80 - 2.20. The correct density range is 2.70 - 3.30.

The incorrect information is located on the DVD software for the VITEK 2 7.01 system. All other product documentation has the correct inoculum density.
Recall Action Recall for Product Correction
Recall Action Instructions bioMerieux is advising end users of the incorrect inoculum density range and requesting that the recall letter be kept with the instrument documentation. bioMerieux will update the VITEK 2 7.01 Product Information to include the correct DensiCHEK inoculation concentration. This action has been closed-out on 09/08/2016.
Contact Information 1800 333 421 - bioMérieux Australia - Technical Assistance Department