Exact FDA event identifier

Event 72760

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

Open FDA event record

Event summary

Timeline bucket: November 23, 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

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

Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.

Z-0556-2016

Recall number: Z-0556-2016
Initiated: November 23, 2015
Classification: Class II
Status: Terminated
Recalling firm: Biomerieux Inc
Quantity: 24 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.

Code information

REF 42722 - Lot Numbers 896, 897 & 899

Distribution pattern

US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.