Recall Z-1519-06 ยท NJT Immunohistochemistry Reagents And Kits
Biogenex Laboratories
Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
| Date | Sep 23, 2006 (initiated Sep 5, 2006) |
| Status | Terminated |
| Reason | Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67. |
| Root cause | Other |
| Action | On 9/5/06, the firm issued a notification letter to the consignees with a correct label to apply, and a return the reply form included with the letter. |
| Quantity | 13 vials. |
| Distribution | Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.