Exact FDA event identifier

Event 64327

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: February 06, 2013
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

1 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 1

bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.

Z-1013-2013

Recall number: Z-1013-2013
Initiated: February 06, 2013
Classification: Class II
Status: Terminated
Recalling firm: Biomerieux Inc
Quantity: 4/20-card cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

Code information

lot number: 540274420

Distribution pattern

Distributed only in HI.