Recall Z-0073-2007
Sebia, Inc. · initiated August 29, 2006
Product
HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France
Codes / lots: Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.
Reason for recall
The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
FDA-determined cause: Other
Action taken
Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.
Details
- Recall number
- Z-0073-2007
- Initiated
- August 29, 2006
- Posted by FDA
- October 25, 2006
- Terminated
- January 28, 2010
- Product code
- JBD – System, Analysis, Electrophoretic Hemoglobin
- 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
- Recalling firm
- Sebia, Inc., Norcross, GA