HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de
FDA device recall Z-0073-2007 · posted 2006-10-25 · Terminated
Recall details
- Recalling firm
- Sebia, Inc.
- Reason for recall
- The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
- Action taken
- Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- JBD
- Quantity affected
- 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
- Date initiated
- 2006-08-29
- Date posted
- 2006-10-25
- Date terminated
- 2010-01-28
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) (K991362) | Morax | 1999-06-21 |