Medical device recalls Moderate risk

Northeast Laboratory Services, Inc. recalls NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screen…

Recall date
December 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1314-2016
FDA classification
Class II
Brand / firm
Northeast Laboratory Services, Inc.
Sold / distributed
Nationwide Distribution.

Why it was recalled

Product marketed without a 510 (k)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).

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