Z-0603-2024Class II

ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

Name: Z-0603-2024 ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Creator: Zeus Scientific, Inc.
Published: 2023-10-31
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2023-10-31 / Open, Classified / root cause: design

FDA source

Zeus Scientific, Inc. began a recall of ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G on 2023-10-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0603-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-31
Posted: 2023-12-21
Recalling firm: Zeus Scientific LLC
Product: ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Product code: MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
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.
Root cause tag: design
FDA root cause: Device Design
Action: An URGENT NOTICE Medical Device Recall was sent to customers on 10/31/23. Actions to be Taken: Please identify and discontinue use of the above product immediately. In addition, quarantine all unused product in preparation for returning it to ZEUS Scientific. If you have used all the above product(s), please indicate as such on the attached Medical Device Recall Reply Form. If you have any product with this lot number, please identify, discontinue use, and quarantine all unused product in preparation for returning it. In addition, please indicate the quantity of kits remaining in inventory on the attached Medical Device Recall Reply Form. Finally, if you have any kits in inventory, please contact ZEUS Scientific Technical Service at [email protected] for return shipment instructions. If you have questions about the recall or would like to notify our organization of an adverse event, please contact us at [email protected] . Additionally, please contact FDA MedWatch in the case you will need to report an adverse event, using the toll-free information line, 1-888-INFO-FDA (1-888-463-6332) and press 2 to report into MedWatch or for instructions. Our regulatory policy requires signed verification of this notice on the Medical Device Recall Reply Form. Please sign in the space provided and return that page via Fax or email to [email protected].
Quantity in commerce: 293 kits
Distribution: US States: CA, MA, MI, NJ, NY, TN, UT.
Product codes and lots: UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0603-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0602-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21
Z-0603-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21

Product code MYL

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)