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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 scree
Recalled April 13, 2016 · FDA recall Z-1314-2016 · Northeast Laboratory Services
Hazard
Product marketed without a 510 (k) · FDA Class II
Units
11720
Sold at
Nationwide Distribution.
Description
Product marketed without a 510 (k)
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).
Manufacturer(s)
Northeast Laboratory Services, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →