Recall archive / FDA device enforcement
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G — FDA record Z-0603-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
- Reason
- The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
- Classification
- Class II
- Recalling firm
- Zeus Scientific, Inc.
- Quantity
- 293 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0603-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US States: CA, MA, MI, NJ, NY, TN, UT.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Oct 31, 2023
- Center classification date
- Dec 21, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.