ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Reported: December 27, 2023 Initiated: October 31, 2023 #Z-0603-2024
Product Description
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Reason for Recall
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.
Details
- Recalling Firm
- Zeus Scientific, Inc.
- Units Affected
- 293 kits
- Distribution
- US States: CA, MA, MI, NJ, NY, TN, UT.
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G. Recalled by Zeus Scientific, Inc.. Units affected: 293 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2023. Severity: Moderate. Recall number: Z-0603-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11