Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ZEUS ELISA Parvovirus B19 IgM Test System Recalled by Zeus Scientific, Inc. Due to FDA inspection identified that due to increased positivity...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zeus Scientific, Inc. directly.
Affected Products
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.
Quantity: 74
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zeus Scientific, Inc.
Zeus Scientific, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report