NEL GBS Medium 20 ml in 100x15mm plate — Class II medical device recall Z-1313-2016
Terminated recall by Northeast Laboratory Services, Inc., reported 2016-04-13, distributed nationwide. Product marketed without a 510 (k)
| Recall number | Z-1313-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northeast Laboratory Services, Inc., Winslow, ME, United States |
| Recall initiated | 2015-12-21 |
| Classified | 2016-04-01 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 9,300 |
| Model numbers | P8000 |
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 for recall
Product marketed without a 510 (k)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1313-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.