Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 20, 2015
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.
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomerieux Inc recalled Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. I… - a moderate-severity action.
Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. I… was recalled by Biomerieux Inc in May 20, 2015. Reason: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.. Check the official notice for the remedy. Verify recall #Z-1603-2015 with the FDA Devices before acting.
The recall
Biomerieux Inc issued this moderate-severity FDA Devices recall-The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258..
- Moderate
- severity level
- Class II
- classification
- May 20, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1603-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1603-2015) was formally reported on May 20, 2015, with the manufacturer initiating the action on March 27, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomerieux Inc is listed as the recalling firm, operating out of Hazelwood, MO. Federal records list the affected scope as 1604/20-card cartons.
The documented reason for this recall is: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. Distribution data in the federal record shows the product reached: Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1604/20-card cartons
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1603-2015 |
| Date reported | May 20, 2015 |
| Date initiated | March 27, 2015 |
| Recalling firm | Biomerieux Inc |
| Firm location | Hazelwood, MO |
| Affected scope | 1604/20-card cartons |
| Distribution | Distributed only to foreign subsidiaries and distributors, including Canada and Mexico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1603-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomerieux Inc. Units affected: 1604/20-card cartons.
Why was this product recalled? ▼
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Moderate. Recall number: Z-1603-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed only to foreign subsidiaries and distributors, including Canada and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1603-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 20, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.