Diasorin Recalls Parvovirus B19 IgG EIA Kit Due to Labeling Error
Diasorin Inc. is recalling 615 units of the Parvovirus B19 IgG EIA kit because the printed label inside the box lid contains an incorrect Lot Specific Constant value.
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 specific defect is a minor labeling error (incorrect Lot Specific Constant) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Diasorin Inc. is recalling 615 units of the Parvovirus B19 IgG EIA kit, Part No. V519IGUS. The recall is limited to Lot 71440040AA. The product was distributed in New Jersey, Wisconsin, New York, North Carolina, Minnesota, California, Illinois, Virginia, Massachusetts, Michigan, Connecticut, and Canada.
The recall was initiated because the printed label inside the box lid of the Parvovirus B19 kit has the incorrect Lot Specific Constant value. This is a labeling error that may affect the accuracy of the test results or the proper identification of the lot.
Healthcare facilities and laboratories that have purchased this specific lot should stop using the product and contact Diasorin Inc. for instructions on how to return the affected units.
The recalled product
- Product
- Parvovirus B19 IgG EIA kit Part No. V519IGUS
- Manufacturer
- Diasorin Inc.
- Hazard
- Affected units
- 615
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)
- Lot 71440040AA
Distribution
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