Exact FDA event identifier

Event 73325

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

Event summary

Timeline bucket: December 21, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Northeast Laboratory Services, 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

2 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 2

NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

Z-1313-2016

Recall number: Z-1313-2016
Initiated: December 21, 2015
Classification: Class II
Status: Terminated
Recalling firm: Northeast Laboratory Services, Inc.
Quantity: 9300

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product marketed without a 510 (k)

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

Product marketed without a 510 (k)

Code information

Al lot codes

Distribution pattern

Nationwide Distribution.

device · product 2 of 2

NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

Z-1314-2016

Recall number: Z-1314-2016
Initiated: December 21, 2015
Classification: Class II
Status: Terminated
Recalling firm: Northeast Laboratory Services, Inc.
Quantity: 11720

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product marketed without a 510 (k)

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

Product marketed without a 510 (k)

Code information

Al lot codes

Distribution pattern

Nationwide Distribution.