Recall Z-1016-2010 ยท KEY Stainer, Tissue, Automated
Biogenex Laboratories
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for flu
| Date | Mar 8, 2010 (initiated Jan 23, 2009) |
| Status | Terminated |
| Reason | Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution. |
| Root cause | Device Design |
| Action | On 1/23/09, the firm issued an Advisory Notice to all its direct consignees, informing them of the affected product and providing instructions on the recall. Please contact BioGenex Technical Support at 1-800-421-4149 for any assistance you may need. |
| Quantity | 12 units |
| Distribution | The firm distributed the product to one (1) distributor as a consignee of our product. The firm indicated that no customer has received the product directly from BioGenex, due to the fact that the product is exclusive distributed by Abbott Molecular. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.