ZEUS ELISA Parvovirus B19 IgG Test System recallZ-0602-2024 · Zeus Scientific, Inc. · initiated Oct 31, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zeus Scientific, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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].
Recall details
- Recall number
- Z-0602-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 31, 2023
- Posted by the FDA
- Dec 21, 2023
- Recalling firm
- Zeus Scientific, Inc.
- Quantity
- 296 kits
- Product code
- MYL
- FDA submissions
- P150045
- Distribution
- US States: CA, MA, MI, NJ, NY, TN, UT.
Product description
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Code information (models, lots, serial numbers)
UDI: (01)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)23060218; Lot Numbers: 23030068 23060217 23060218
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- ZEUS ELISA Parvovirus B19 IgG Test System SM9Z7701GZeus Scientific, Inc.2 recalls0 reports
- ZEUS ELISA Parvovirus B19 IgM Test System p 9Z7701MZeus Scientific, Inc.1 recall0 reports
- ZEUS ELISA Parvovirus B19 IgM Test System SM9Z7701MZeus Scientific, Inc.1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93514).
- Z-0603-2024 · Open, ClassifiedZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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