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-0400-2011 · Posted 2010-11-17
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Recalling FirmAbbott Point Of Care Inc.
Recall StatusTerminated
Product CodeJBP
Date Initiated2010-10-06
Date Terminated2012-08-22
Product Quantity95,325 cartridges
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.
Firm 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.
Root Cause
Other
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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