# FDA recall Z-3026-2020

> **Zeus Scientific, Inc.** · Class II · device recall initiated 2019-08-12.

## Product

ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.

## Reason for recall

FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.

## Key facts

- **Recall number:** Z-3026-2020
- **Recalling firm:** Zeus Scientific, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-12
- **Report date:** 2020-10-07
- **Termination date:** 2022-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branchburg, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3026-2020

## Citation

> AI Analytics. FDA recall Z-3026-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3026-2020. Source: US FDA. Licensed CC0.

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