Z-1602-2015Class II

Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the...

Name: Z-1602-2015 Vitek 2 AST-YS07 REF 414 967, 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-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... 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-1602-2015
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-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.
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 FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.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: 43,535/20-card cartons
Distribution: Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Product codes and lots: lot 287303120, 02-APR-15; lot 287303122, 02-APR-15; lot 287306710, 08-MAY-15; lot 287308210, 23-MAY-15; lot 287311710, 27-JUN-15; lot 287314910, 29-JUL-15; lot 287314912, 29-JUL-15; lot 287315710, 06-AUG-15; lot 287317310, 22-AUG-15; lot 287317710, 26-AUG-15; lot 287318920, 07-SEP-15; lot 287319110, 09-SEP-15; lot 287319820, 16-SEP-15; lot 287321940, 07-OCT-15; lot 287322540, 13-OCT-15; lot 287323520, 23-OCT-15; lot 287324220, 30-OCT-15; lot 287324240, 30-OCT-15; lot 287326220, 19-NOV-15; lot 287327620, 03-DEC-15; lot 287329620, 23-DEC-15; lot 287330520, 01-JAN-16; lot 287331920, 15-JAN-16; lot 287332520, 21-JAN-16; lot 287332522, 21-JAN-16; lot 287334810, 13-FEB-16; lot 287335420, 19-FEB-16; lot 287336220, 27-FEB-16; lot 287337620, 12-MAR-16; lot 287338020, 16-MAR-16; lot 287340140, 06-APR-16; lot 287341820, 23-APR-16; lot 287341822, 23-APR-16; lot 287344620, 21-MAY-16; lot 287344622, 21-MAY-16; lot 287346710, 11-JUN-16; lot 287346720, 11-JUN-16; lot 287350120, 15-JUL-16; and lot 287350122, 15-JUL-16.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1602-2015
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)