Z-1603-2015Class II

Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the...

Name: Z-1603-2015 Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the...
Creator: Biomerieux Inc
Published: 2015-03-27
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2015-03-27 / Terminated

FDA source

Biomerieux Inc began a recall of 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... on 2015-03-27. FDA classified it as Class II and gives the reason as "The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1603-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-27
Posted: 2015-05-12
Terminated: 2017-03-24
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: LTW Susceptibility Test Cards, Antimicrobial
Reason for recall: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
FDA root cause: Other
Action: The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
Quantity in commerce: 1604/20-card cartons
Distribution: Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Product codes and lots: lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1603-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1601-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-12
Z-1602-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-12
Z-1603-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-12

Product code LTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)