FDA Medical Device Recalls (openFDA)
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).
- Recall number
- Z-1314-2016
- Recalling firm
- Northeast Laboratory Services, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2015-12-21
- Posted
- 2016-04-01
- Terminated
- 2016-04-07
- 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.
- Lot, serial or model codes
- Al lot codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSI
- Firm FEI
- 1210083
- Firm city
- Winslow
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28