i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 Product of Canada
FDA Recall Z-0364-2007 · Posted 2007-01-23
Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2006-12-12
Date Terminated2007-08-15
Product Quantity14,045 boxes of 24
Reason for Recall
Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.
Firm Action
Customers were notified by letter sent by regular mail on 12/13/2006.
Root Cause
Other
Distribution Pattern
Nationwide to hospitals and health care facilities
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.