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.
This recall has been terminated (originally issued February 23, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- August 18, 2009
- Posted
- February 23, 2010
- Terminated
- May 18, 2010
- Recall Number
- Z-0814-2010
- Quantity
- 1,110,775 Cartridges
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution.
Lot / Code Info
Catalog number: 07G81-01
Root Cause
Labeling False and Misleading
Action Taken
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.
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