Northeast Laboratory Services Recalls GBS Medium for Missing 510(k) Clearance
Northeast Laboratory Services is recalling 9,300 units of GBS Medium because the product was 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 explicitly states no illnesses or injuries were reported and the hazard is regulatory (missing 510(k) clearance) rather than a direct physical or biological threat, fitting the 'voluntary precautionary' or 'minor labeling/regulatory' criteria for a score of 2.
Plain-English summary
Northeast Laboratory Services, Inc. is recalling 9,300 units of NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish), Catalog No. P8000. 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 FDA.
The affected units were distributed nationwide. The source text does not specify particular lot codes, dates, or specific facilities affected. No illnesses or injuries have been reported in connection with this recall.
Consumers and healthcare facilities should stop using the affected product and contact Northeast Laboratory Services, Inc. for further instructions or a refund.
The recalled product
- 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).
- Manufacturer
- Northeast Laboratory Services, Inc.
- Affected units
- 9,300
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.
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