Recall Z-3026-2020 ยท MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
Zeus Scientific, Inc.
ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.
| Date | Aug 12, 2019 |
| Status | Terminated |
| Reason | FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer. |
| Root cause | Unknown/Undetermined by firm |
| Action | Pending. The firm has not initiated customer notification for this issue. |
| Quantity | 74 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, CT, IN, NJ, TX and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.