Vitek 2 AST-YS07 REF 414 967 — Class II medical device recall Z-1602-2015
Terminated recall by Biomerieux Inc, reported 2015-05-20. The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
| Recall number | Z-1602-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2015-03-27 |
| Classified | 2015-05-12 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2017-03-24 |
| Countries outside the US | CA, MX |
| Lot numbers | 287303120, 287303122, 287306710, 287308210, 287311710, 287314910, 287314912, 287315710, 287317310, 287317710, 287318920, 287319110, 287319820, 287321940, 287322540, 287323520, 287324220, 287324240, 287326220, 287327620, 287329620, 287330520, 287331920, 287332520, 287332522, 287334810, 287335420, 287336220, 287337620, 287338020, 287340140, 287341820, 287341822, 287344620, 287344622, 287346710, 287346720, 287350120, 287350122 |
| Model numbers | 414, 967 |
Product
Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
Reason for recall
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1602-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.