i-STAT Celite ACT Cartridge. ACT, activated clotting time… recallZ-0912-05 · Abbott Laboratories · initiated Mar 16, 2005
Terminated All recalls posted in June 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
FDA root cause category: Other
What the company is doing
The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.
Recall details
- Recall number
- Z-0912-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 16, 2005
- Posted by the FDA
- Jun 21, 2005
- Recalling firm
- Abbott Laboratories
- Quantity
- 298006 cartridges
- Product code
- JBP
- FDA submissions
- K992571
- 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.
Code information (models, lots, serial 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.
Other devices under the same FDA submission
1 device cleared under K992571 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 03P86-25Abbott Point Of Care Inc. · ACTIVATED WHOLE BLOOD CLOTTING TIME27 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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