Recall Z-0603-2024 ยท MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
Zeus Scientific, Inc.
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
| Date | Dec 21, 2023 (initiated Oct 31, 2023) |
| Status | Open, Classified |
| 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 o |
| Quantity | 293 kits |
| Distribution | US States: CA, MA, MI, NJ, NY, TN, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.