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U.S. Department of Health and Human Services

Class 2 Device Recall ZEUS ELISA Parvovirus B19 IgG

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 Class 2 Device Recall ZEUS ELISA Parvovirus B19 IgGsee related information
Date Initiated by FirmOctober 31, 2023
Date PostedDecember 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0602-2024
Recall Event ID 93514
PMA NumberP150045 
Product Classification Assay,enzyme linked immunosorbent,parvovirus b19 igg - Product Code MYL
ProductZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Code Information UDI: (01)00845533001748(17)240731(10)23030068 (01)00845533001755(17)241130(10)23060217 (01)00845533001779(17)241130(10)23060218; Lot Numbers: 23030068 23060217 23060218
FEI Number 2242436
Recalling Firm/
Manufacturer		 Zeus Scientific, Inc.
199 Evans Way
Branchburg NJ 08876-4600
For Additional Information ContactAlicia Barrett, MT (ASCP)
908-243-4942
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAn 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 in Commerce296 kits
DistributionUS States: CA, MA, MI, NJ, NY, TN, UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MYL
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