Sebia, Inc. HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France
Brand
Sebia, Inc.
Lot Codes / Batch Numbers
Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.
Products Sold
Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.
Sebia, Inc. is recalling HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vi due to The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
Recommended Action
Per FDA guidance
Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026