Recall Z-2038-2016 ยท NJT Immunohistochemistry Reagents And Kits
Cell Marque Corporation
SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
| Date | May 10, 2016 |
| Status | Terminated |
| Reason | Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result. |
| Root cause | Unknown/Undetermined by firm |
| Action | Product recall notifications were sent to customers on May 12, 2016. Letters advised that all unused or partially-used vials be destroyed. Customers should contact customer service for replacement and credit. |
| Quantity | 23 units |
| Distribution | Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133845 | 8MM TROCAR KIT Intuitive Surgical, Feb 19, 2014 |