Z-0400-2011

i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose...

Name: Z-0400-2011 i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose...
Creator: Abbott Point Of Care Inc.
Published: 2010-10-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-10-06 / Terminated

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with... on 2010-10-06. The reason FDA records is "Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0400-2011
Status: Terminated
Initiated: 2010-10-06
Posted: 2010-11-17
Terminated: 2012-08-22
Recalling firm: Abbott Medical
Product: 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: Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
FDA root cause: Other
Action: Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material. Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.
Quantity in commerce: 95,325 cartridges
Distribution: Worldwide Distribution
Product codes and lots: List numbers: 07G81-01, 07G81-02; Lot numbers: S10129, S10129A, S10130, S10130B, S10147A, S10147B, S10147C, S10147D, S10147E, S10148A, S10148B, S10148C, S10148D, S10148G, S10149, S10149B, S10149C, S10151A, S10151B, S10152, S10152A, S10152B, S10152C, S10152D, S10152E, S10152F, S10154A, S10154B, S10154D, S10160B, S10162.

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)