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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73325

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

Open FDA event record

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
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
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.