Z-0073-2007

HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue...

Name: Z-0073-2007 HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue...
Creator: Sebia, Inc.
Published: 2006-08-29
License: https://open.fda.gov/license/

Sebia, Inc. / initiated 2006-08-29 / Terminated / root cause: packaging

FDA source

Sebia, Inc. began a recall of HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France on 2006-08-29. The reason FDA records is "The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0073-2007
Status: Terminated
Initiated: 2006-08-29
Posted: 2006-10-25
Terminated: 2010-01-28
Recalling firm: Sebia, Inc.
Product: HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France
Product code: JBD System, Analysis, Electrophoretic Hemoglobin
Reason for recall: The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.
Quantity in commerce: 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
Product codes and lots: Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.

Product code JBD

K991362Class IIHydragel Hemoglobin(e), Mini Hemoglobin(e), 7 Hemoglobin(e), 15 Hemoglobin(e), Acid(e) Hemoglobin(e), Mini Acid(e) Hemo)Morax / cleared 1999-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)