Abbott Point of Care Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Point of Care Inc.
Lot Codes / Batch Numbers
Catalog number: 07G01-1
Products Sold
Catalog number: 07G01-1
Abbott Point of Care Inc. is recalling Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate and high-lev due to 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 v. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026