Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00378-1
Product Name/Description VITEK2 AST-YS06 & VITEK2 AST-YS07 Test Kits

Catalogue numbers: 412610 & 414967

Lot numbers: 286303720, 287314910, 287314912, 287317310, 287318920, 287321940, 287323520, 287329620, 287330520, 287334810, 287336220, 287340140, 287344620, 287344622, 287346710, 287350120 & 287350910

Pack size: 20 Cards

ARTG number: 196634
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 1/05/2015
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue An issue related to Out-of-Range-Low (OORL) Flucytosine (FCT) QC results for Candida krusei ATCC 6258, the Package Insert QC strain, has been identified in association with the VITEK 2 AST-YS06 and AST-YS07 test kits.

Internal investigation at the manufacturing site has observed the OORL FCT QC results for Candida krusei ATCC 6258. Internal testing of FCT with additional isolates shows a trend to call one to two doubling dilutions low. Candida krusei are intrinsically resistant to FCT and are therefore forced "resistant" in VITEK 2 software (as of version 7.01); the VITEK® 2 7.01 FCT forcing rule does not apply to other Candida species. User reports have been limited to the ATCC 6258 QC strain; however, impact to patient results for Candida krusei and other yeast cannot be ruled out.
Recall Action Recall for Product Correction
Recall Action Instructions For the referenced test kits (VITEK 2 AST-YS06 or AST-YS07), laboratories are advised to not report Flucytosine (FCT) results for any organism until the new formulation (fct02n) is released.

This issue will be resolved with the release of a new Flucytosine (fct02n) formulation. The estimated timeframe for introduction of cards with the new Flucytosine formulation is six months. This action has been closed out on 09/08/2016.
Contact Information 1800 333 421 - bioMérieux Technical Assistance