Abbott Laboratories i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
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.
Products Sold
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.
Abbott Laboratories is recalling i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. due to Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
Recommended Action
Per FDA guidance
The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026