Medscience AllergiEnd Skin Test Applicators Recalled for Lack of Clearance
Medscience Inc is recalling AllergiEnd ST-9 skin test applicators and trays because they were marketed without FDA 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, which typically corresponds to a moderate severity score. The hazard is a regulatory compliance issue (lack of 510(k) clearance) rather than a direct physical defect or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Medscience Inc is voluntarily recalling the AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and the AllergiEnd ST-9 Multiple Well Test Tray (Item 1001). The recall involves 11,400 units of Item 1000 and 380 units of Item 1001. These products are designed to perform multi-site skin tests to identify reactions to certain allergens using a non-invasive applicator containing 70 different allergens and histamine.
The recall was initiated after an FDA inspection determined that the products were marketed without a cleared 510(k) premarket notification. This regulatory deficiency means the devices were distributed without the required FDA clearance for safety and effectiveness.
The products were distributed nationwide to Arizona, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Maryland, Michigan, New Jersey, New York, Pennsylvania, Texas, Virginia, and Washington. All lots are affected. Consumers and healthcare providers should stop using these products and contact Medscience Inc for further instructions.
The recalled product
- Product
- AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator…
- Manufacturer
- Medscience Inc
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)
- All lots
Distribution
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