Devices

i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.

Model / Serial
i-STAT Catalog Number -- 420300; Abbott Catalog Number -- 07G01-01 (USA and Canada); Abbott Catalog Number -- 07G10-02 (Rest of world). Lot Numbers: R04174B; R04175; R04175A; R04183; R04183A; R04183B; R04183C; R04190A; R04190B; R04205; R04205A; R04212A; R04212B; R04233; R04239; R04245; R04245A; R04245B; R04253; R04261; R04261A; R04262; R04274; R04274A; R04275; R04293; R04293A; R04294; R04294A; R04305; R04305A; R04305B; R04306; R04309; R04309A; R04315; R04315A; R04315B; R04322; R04323; R04323A; R04329; R04337; R04337A; R04342; R04343; R04350; R04350A; R04350B; R05006; R05014; R05014A; R05032B; R05032C; R05043; R05043A; R05044; R05048B; R05048C.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The cartridges have been distributed to hospitals and clinics nationwide. The cartridges have been distributed to Austria, Australia, Canada, Switzerland, China, Colombia, Germany, France, Greece, Hong Kong, India, New Zealand, and Singapore. There are 15 VA hospitals identified. There are 3 government and military accounts.
Product Description
i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
Manufacturer
Abbott Laboratories
1 Event
- Recall of i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.

Manufacturer

Abbott Laboratories

Manufacturer Address
Abbott Laboratories, 104 Windsor Center Dr, East Windsor NJ 08520-1407
Source
USFDA

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