Recall Z-0073-2007 ยท JBD System, Analysis, Electrophoretic Hemoglobin
Sebia, Inc.
HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France
| Date | Oct 25, 2006 (initiated Aug 29, 2006) |
| Status | Terminated |
| Reason | The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction. |
| Root cause | Other |
| Action | Consignees were notified via fax letter and also by phone contact on or about 08/29/2006. |
| Quantity | 71 kits |
| Distribution | Nationwide (AL, CA, CO, FL, GA, IL, KA, LA, MD, MI, NM, NC, NJ, NY, PA, TX, VA, WI) and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) Morax, Jun 21, 1999 |