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.
FDA Recall Z-0814-2010 · Posted 2010-02-23
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Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeJBP
Date Initiated2009-08-18
Date Terminated2010-05-18
Product Quantity1,110,775 Cartridges
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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