ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.
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: This is a Class II recall without reported illnesses or injuries. The issue is regulatory non-compliance—an unapproved modification to the test conjugate. Without explicit evidence of harm, this is characterized as a moderate procedural issue.
Plain-English summary
Zeus Scientific is recalling certain ZEUS ELISA Parvovirus B19 IgM Test System kits (Product Number SM9Z7701G). The organization completed a product improvement process to the conjugate within these kits, and this modification was not reviewed and approved by the FDA prior to its implementation.
The recall affects 293 kits distributed to facilities in California, Massachusetts, Michigan, New Jersey, New York, Tennessee, and Utah. The affected lot numbers are 23030069, 23060238, and 23060239.
The recalled product
- Product
- ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
- Manufacturer
- Zeus Scientific, Inc.
- Hazard
- Affected units
- 293
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 Numbers: 23030069 23060238 23060239
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zeus Scientific, 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 · Zeus Scientific, Inc.
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