Recall Z-1471-2008 ยท KEY Stainer, Tissue, Automated
Biogenex Laboratories
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
| Date | Aug 22, 2008 (initiated Jan 24, 2008) |
| Status | Terminated |
| Reason | Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals. |
| Root cause | Component design/selection |
| Action | The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall. |
| Quantity | 10 units distributed. |
| Distribution | Product was distributed to a single distributor, which further distributed the product. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.