Reported Dec 27, 2023 · Ongoing

ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

Zeus Scientific, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zeus Scientific, Inc. · 199 Evans Way · Branchburg, NJ · 08876-4600

Is this the product you have?

    • ZEUS ELISA Parvovirus B19 IgM Test System
    • Product Number SM9Z7701G
Lot codes and dates
  • UDI(01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239
  • Lot Numbers23030069 23060238 23060239
Amount recalled
293 kits

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.