CLASS II Device recall · Reported 20 May 2015 · FDA Enforcement Report
Vitek 2 AST-YS01 recalled by Biomerieux
Biomerieux is recalling Vitek 2 AST-YS01. The recall was initiated on 27 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1603-2015
- FDA event ID
- 70868
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Mar 2015
- FDA classified
- 12 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Mold
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Mar 2015 | Recall initiated by company | |
| 12 May 2015 | Classified by FDA | +46 days |
| 20 May 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Product as listed by the FDA
Vitek 2 AST-YS01 REF 22 108, 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.
Where it was distributed
Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Questions about this recall
Is Vitek 2 AST-YS01 recalled?
Yes. Biomerieux recalled Vitek 2 AST-YS01 on 27 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1603-2015.
Why was it recalled?
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Which lots are affected?
lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.
Where was it sold?
Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biomerieux
All 476| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux | Biomerieux | Other | Nationwide |
| Device | CLASS II | Vitek-negative Susceptibility Cards Containing o Polymyxin recalled | Biomerieux | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux | bioMerieux | Mold | Nationwide |
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