ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.
What this means for you
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 an FDA Class II recall involving an unapproved manufacturing modification. No illnesses, injuries, or test failures have been reported in the source text. The recall addresses a regulatory compliance violation rather than a documented patient safety incident.
Plain-English summary
Zeus Scientific, Inc. has recalled 296 units of ZEUS ELISA Parvovirus B19 IgG Test System (Product Number SM9Z7701M) due to an unapproved modification made to the conjugate (test reagent) in these kits.
The manufacturer completed a product improvement process that modified a key component of the test system without prior review and approval from the U.S. Food and Drug Administration (FDA). Regulatory requirements mandate that manufacturers obtain FDA approval for modifications to medical device composition or manufacturing processes before implementation.
The affected kits were distributed to healthcare providers and laboratories in seven U.S. states: California, Massachusetts, Michigan, New Jersey, New York, Tennessee, and Utah. The specific lot numbers involved are 23030068, 23060217, and 23060218.
Healthcare facilities and laboratories that have received these kits should discontinue use and contact Zeus Scientific for return or replacement instructions. Providers with questions about test results from these lots should consult their healthcare provider or Zeus Scientific.
The recalled product
- Product
- ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
- Manufacturer
- Zeus Scientific, Inc.
- Hazard
- unapproved-modification
- regulatory-violation
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: 23030068 23060217 23060218
Distribution
Distributed in 7 states:
- CA
- MA
- MI
- NJ
- NY
- TN
- UT
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