Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18488 |
| Brand Name: | Biomerieux Vitek2 AST-YS07 Test Kits |
| Model: | Catalogue numbers: 414967 |
| Affected: | Lot numbers: 287314910, 287317310, 287323520, 287336220, 287340140 |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | BioMerieux Inc |
| 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 type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/5/2015 |
