FDA Device

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

Hazard

Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.

What You Should Do

Remedy

The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.

Products

i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
Brand
Abbott Laboratories
UPC
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.

Units Affected

298006 cartridges