FDA Medical Device Recalls (openFDA)
Zeus Scientific, Inc.: ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
- Recall number
- Z-0603-2024
- Recalling firm
- Zeus Scientific, Inc.
- Product
- ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
- Status
- Open, Classified
- Initiated
- 2023-10-31
- Posted
- 2023-12-21
- Terminated
- not on file
- Reason
- 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
- 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 support@zeusscientific.com 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 regulatory@zeusscientific.com . 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 regulatory@zeusscientific.com.
- Quantity
- 293 kits
- Distribution
- US States: CA, MA, MI, NJ, NY, TN, UT.
- Lot, serial or model codes
- UDI: (01)00845533001724(17)240731(10)23030069 (01)00845533001724(17)241231(10)23060238 (01)00845533001748(17)241231(10)23060239; Lot Numbers: 23030069 23060238 23060239
- 510(k) numbers
- not on file
- PMA numbers
- ["P150042"]
- Product code
- MYL
- Firm FEI
- 2242436
- Firm city
- Branchburg
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28