Recall Z-1314-2016— Northeast Laboratory Services, Inc.

Name: FDA recall Z-1314-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-21

Class II · Terminated

Class II FDA medical device recall by Northeast Laboratory Services, Inc., initiated 2015-12-21, terminated 2016-04-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Product marketed without a 510 (k).

Recalling firm: Northeast Laboratory Services, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Terminated: 2016-04-07
Firm location: Winslow, ME, United States

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.