NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selecti...
FDA Recall #Z-1314-2016 — Class II — December 21, 2015
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)
Recalling Firm
Northeast Laboratory Services, Inc. — Winslow, ME
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11720
Distribution
Nationwide Distribution.
Code Information
Al lot codes
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated