FDA Device recall Z-1313-2016
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000
- FDA Device
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000 by Northeast Laboratory Services, citing product marketed without a 510 (k).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1313-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-21 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Northeast Laboratory Services |
| Distribution | US |
Product
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
Reason
Product marketed without a 510 (k)
Identifiers
| code_info | Al lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1313-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.