Z-3026-2020Class II

ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 -

Name: Z-3026-2020 ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 -
Creator: Zeus Scientific, Inc.
Published: 2019-08-12
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2019-08-12 / Terminated

FDA source

Zeus Scientific, Inc. began a recall of ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human... on 2019-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3026-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-12
Posted: 2020-09-29
Terminated: 2022-05-20
Recalling firm: Zeus Scientific LLC
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.
Product code: MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
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.
FDA root cause: Unknown/Undetermined by firm
Action: Pending. The firm has not initiated customer notification for this issue.
Quantity in commerce: 74
Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada.
Product codes and lots: Lot 19040014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3026-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3026-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-29

Product code MYM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)