ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M

FDA device recall Z-0602-2024 · posted 2023-12-21 · Open, Classified

Recall details

Recalling firm

Zeus Scientific, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

MYL

Quantity affected

296 kits

Distribution

US States: CA, MA, MI, NJ, NY, TN, UT.

Date initiated

2023-10-31

Date posted

2023-12-21

Location

Branchburg, NJ