ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: (01)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)23060218; Lot Numbers: 23030068 23060217 23060218
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zeus Scientific, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Product Codes/Lot Numbers:
UDI: (01)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)23060218; Lot Numbers: 23030068 23060217 23060218
Distribution:
Distributed in: US, CA, MA, MI, NJ, NY, TN, UT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0602-2024
Related Recalls
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.
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.
Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.