Northeast Laboratory Services Recalls GBS Medium Tubes for Missing 510(k) Clearance
Northeast Laboratory Services is recalling 11,720 units of GBS Medium tubes because they were marketed without FDA 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is regulatory (missing clearance) rather than a direct physical safety defect.
Plain-English summary
Northeast Laboratory Services, Inc. is recalling 11,720 units of NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube, Catalog No.: T8000). The product is used for the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
The recall was initiated because the product was marketed without a 510(k) clearance from the U.S. Food and Drug Administration. The agency has classified this recall as Class II.
The product was distributed nationwide. Users of the product should stop using it and contact the recalling firm for further instructions.
The recalled product
- 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).
- Manufacturer
- Northeast Laboratory Services, Inc.
- Affected units
- 11,720
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Al lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Northeast Laboratory Services, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Northeast Laboratory Services, Inc.
See all →- ModerateNortheast Laboratory Services Recalls GBS Medium for Missing 510(k) Clearance
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