Zeus ELISA Parvovirus Test (Zeus) – False Positive Risk (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Zeus Scientific, Inc.
Lot Codes / Batch Numbers
Lot 19040014
Products Sold
Lot 19040014
Zeus Scientific, Inc. is recalling ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qual due to FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correcti. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Pending. The firm has not initiated customer notification for this issue.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026