Home / Recalls / Northeast Laboratory Services, Inc. / Z-1314-2016

Z-1314-2016 Class II Terminated

Recalled by Northeast Laboratory Services, Inc. — Winslow, ME

Recall Details

Product Type
Devices
Report Date
April 13, 2016
Initiation Date
December 21, 2015
Termination Date
April 7, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11720

Product Description

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).

Reason for Recall

Product marketed without a 510 (k)

Distribution Pattern

Nationwide Distribution.

Code Information

Al lot codes

Other recalls by Northeast Laboratory Services, Inc.

  • Z-1313-2016 Class II — NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000 (December 21, 2015)