Recall Z-3110-2011 ยท NJT Immunohistochemistry Reagents And Kits
Cell Marque Corporation
Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test metho
| Date | Aug 31, 2011 (initiated Jul 12, 2011) |
| Status | Terminated |
| Reason | Incorrect label on product bottle, although labeling on outer box is correct. |
| Root cause | Labeling mix-ups |
| Action | The firm, Cell Marque, notified customers by telephone on July 12, 2011. The customers were instructed to return the product. Cell Marque immediately issued replacement of the product. If you have any further question or require additional documentation, contact the VP of Regulatory and Quality Affairs at (916) 746-8900. |
| Quantity | 2 units |
| Distribution | Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.