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[Recalled] 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 marketed without a 510 (k) | FDA 2
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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). |
|---|---|
| Brand / manufacturer | Northeast Laboratory Services, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1314-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 December 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Product marketed without a 510 (k)
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Northeast Laboratory Services, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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