Z-0814-2010

Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor...

Name: Z-0814-2010 Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor...
Creator: Abbott Point of Care Inc.
Published: 2009-08-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-08-18 / Terminated / root cause: labeling and UDI

FDA source

Abbott Point of Care Inc. began a recall of Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated... on 2009-08-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0814-2010
Status: Terminated
Initiated: 2009-08-18
Posted: 2010-02-23
Terminated: 2010-05-18
Recalling firm: Abbott Medical
Product: Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
Product code: JBP Activated Whole Blood Clotting Time
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 1,110,775 Cartridges
Distribution: Worldwide distribution.
Product codes and lots: Catalog number: 07G81-01

Product code JBP

K023582Class III-Stat Kaolin Act TestI-Stat Corporation / cleared 2003-09-08

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)