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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