Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0603-2024 — ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

U.S. FDA — Device Enforcement · United States · 2023-10-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0603-2024
Date of alert
2023-10-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zeus Scientific, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00845533001724
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.