Devices

Device Recall Pacific Hemostasis Fibrinogen Degradation Products

Model / Serial
Lot Number 948546, Exp. 9/30/2017
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
USA (nationwide) including Puerto Rico, and Internationally to Colombia
Product Description
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
Manufacturer
Fisher Diagnostics
1 Event
- Recall of Device Recall Pacific Hemostasis Fibrinogen Degradation Products

Manufacturer

Fisher Diagnostics

Manufacturer Address
Fisher Diagnostics, 8365 Valley Pike, Middletown VA 22645-1905
Source
USFDA

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