Abbott i-STAT ACT Celite Cartridges recallZ-0813-2010 · Abbott Point of Care Inc. · initiated Aug 18, 2009
Terminated All recalls posted in February 2010
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 Point of Care Inc. 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
Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.
FDA root cause category: Labeling False and Misleading
What the company is doing
Abbott Point of Care issued an "Important Product Information" letter beginning August 18, 2009. Consignees were instructed on how to reconcile all affected product. For further information, contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1.
Recall details
- Recall number
- Z-0813-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 18, 2009
- Posted by the FDA
- Feb 23, 2010
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 696,675 Cartridges
- Product code
- JBP
- FDA submissions
- K992571
- Distribution
- Worldwide distribution.
Product description
Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
Code information (models, lots, serial numbers)
Catalog number: 07G01-1
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
Other products in the same recall event
The FDA groups related products into one recall event (event 52754).
- Z-0814-2010 · TerminatedAbbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular s…
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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