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Terminated

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.

FDA Recall Z-3026-2020 · Posted None

Recalling FirmZeus Scientific, Inc.
Recall StatusTerminated
Product CodeMYM
Date Initiated2019-08-12
Date Terminated2022-05-20
Product Quantity74

Reason for Recall

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.

Firm Action

Pending. The firm has not initiated customer notification for this issue.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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