Recall Z-0014-05 ยท MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Zymed Laboratories Inc.
Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
| Date | Oct 9, 2004 (initiated Apr 6, 2004) |
| Status | Terminated |
| Reason | Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings. |
| Root cause | Other |
| Action | The firm has conducted telephone calls and visits to its consignees, with confirmation done by phone and fax. The firm has recovered or accounted for 100% of the products, either returned or destroyed. |
| Quantity | 24 vials of the mouse anti-TTF-1 concentrate have been released in distribution. |
| Distribution | The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.