Recall Z-1314-2016 ยท JSI Culture Media, Selective And Differential
Northeast Laboratory Services, Inc.
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).
| Date | Apr 1, 2016 (initiated Dec 21, 2015) |
| Status | Terminated |
| Reason | Product marketed without a 510 (k) |
| Root cause | No Marketing Application |
| 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. |
| Quantity | 11720 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.