Recalls / —

—#38016

Product

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

FDA product code

JBP — Activated Whole Blood Clotting Time

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K992571

Affected lot / code info

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.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm

Abbott Laboratories

Address

104 Windsor Center Dr, East Windsor, New Jersey 08520-1407

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2005-03-16

Posted by FDA

2005-06-21

Terminated

2006-06-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #38016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.