Z-1314-2016Class II

NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment...

Name: Z-1314-2016 NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment...
Creator: Northeast Laboratory Services, Inc.
Published: 2015-12-21
License: https://open.fda.gov/license/

Analytichem USA, Inc. / initiated 2015-12-21 / Terminated

FDA source

Northeast Laboratory Services, Inc. began a recall of 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... on 2015-12-21. FDA classified it as Class II and gives the reason as "Product marketed without a 510 (k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1314-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Posted: 2016-04-01
Terminated: 2016-04-07
Recalling firm: Analytichem USA, 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).
Product code: JSI Culture Media, Selective And Differential
Reason for recall: Product marketed without a 510 (k)
FDA 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 in commerce: 11720
Distribution: Nationwide Distribution.
Product codes and lots: Al lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1314-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1313-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-01
Z-1314-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-01

Product code JSI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)