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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70868

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 27, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomerieux Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Vitek 2 AST-YS06 REF 412 610, 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.

Z-1601-2015
Recall number
Z-1601-2015
Initiated
March 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomerieux Inc
Quantity
1,025/20-card cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

Code information

lot 286303720, expiration 08-APR-15

Distribution pattern

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.

device · product 2 of 3

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.

Z-1602-2015
Recall number
Z-1602-2015
Initiated
March 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomerieux Inc
Quantity
43,535/20-card cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

Code information

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.

Distribution pattern

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.

device · product 3 of 3

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.

Z-1603-2015
Recall number
Z-1603-2015
Initiated
March 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomerieux Inc
Quantity
1604/20-card cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.

Code information

lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.

Distribution pattern

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.