---
title: "ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M — FDA record Z-0602-2024 | Is It on Recall"
description: "The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved b"
url: https://isitonrecall.com/recall/fda-device-z-0602-2024-zeus-elisa-parvovirus-b19-igg-test-system-product-number-sm9z7701m/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M — FDA record Z-0602-2024

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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
- **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**: 296 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0602-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0602-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)23060218; Lot Numbers: 23030068 23060217 23060218 |

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.

- [California](https://isitonrecall.com/state/california/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Utah](https://isitonrecall.com/state/utah/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0602-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Zeus Scientific, Inc. records](https://isitonrecall.com/brand/zeus-scientific-inc/)