Z-0912-05

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

Name: Z-0912-05 i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test
Creator: Abbott Laboratories
Published: 2005-03-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-03-16 / Terminated

FDA source

Abbott Laboratories began a recall of i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test on 2005-03-16. The reason FDA records is "Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0912-05
Status: Terminated
Initiated: 2005-03-16
Posted: 2005-06-21
Terminated: 2006-06-30
Recalling firm: Abbott Medical
Product: i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
Product code: JBP Activated Whole Blood Clotting Time
Reason for recall: Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
FDA root cause: Other
Action: The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.
Quantity in commerce: 298006 cartridges
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 codes and lots: 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 code JBP

K992571Class III-Stat SystemI-Stat Corp. / cleared 2000-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)