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).
FDA Recall Z-1314-2016 · Posted 2016-04-01
Recalling FirmNortheast Laboratory Services, Inc.
Recall StatusTerminated
Product CodeJSI
Date Initiated2015-12-21
Date Terminated2016-04-07
Product Quantity11720
Reason for Recall
Product marketed without a 510 (k)
Firm Action
Northeast Laboratory services issued recall letter dated 2/29/16
and advised users to: Immediately examine your inventory for all lots of these products you may have in stock. Please destroy all remaining product in stock.
Users requested to fill out the questionnaire immediately and return the questionnaire via email or Fax.
Previously Northeast Laboratory Services notified users by letter dated 12/21/15 that the firm has discontinued the products effective January 2016. Alternative products were referenced in the letter for users to transition to replacement product.
Root Cause
No Marketing Application
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.