Devices

Device Recall HYDRAGEL 15 Hemoglobin (E)

Model / Serial
Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide (AL, CA, CO, FL, GA, IL, KA, LA, MD, MI, NM, NC, NJ, NY, PA, TX, VA, WI) and Puerto Rico
Product Description
HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France
Manufacturer
Sebia, Inc.
1 Event
- Recall of Device Recall HYDRAGEL 15 Hemoglobin (E)

Manufacturer

Sebia, Inc.

Manufacturer Address
Sebia, Inc., 400-1705 Corporate Dr., Norcross GA 30093
Source
USFDA

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