FDA Medical Device Recalls (openFDA)
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 number
- Z-0073-2007
- 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
- Status
- Terminated
- Initiated
- 2006-08-29
- Posted
- 2006-10-25
- Terminated
- 2010-01-28
- 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
- Lot, serial or model codes
- Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.
- 510(k) numbers
- ["K991362"]
- PMA numbers
- not on file
- Product code
- JBD
- Firm FEI
- 3001595416
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28