Northeast Laboratory Services, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1313-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: December 21, 2015

Date Posted: April 13, 2016

Recall Number: Z-1313-2016

Event ID: 73325

Reason for Recall:

Product marketed without a 510 (k)

Status: Terminated

Product Quantity: 9300

Code Information:

Al lot codes

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated