Abbott Point of Care Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Abbott Point of Care Inc.
Lot Codes / Batch Numbers
Product list #''s 04J50-01 and 04J50-02, catalog # 420200 Lot numbers: N06227, N06175A, N06176, N06179, N06181, N06186, N06188, N06194, N06195A, N06200A, N06201A, N06201B, N06201C, N06202, N06206, N06206B, N06208, N06208A, N06209, N06222, N06222A, N06222B, N06223, N06227, N06227A, N06227B, N06235, N06235A, N06236A, N06236B, N06237, N06241, N06241A, N06241B, N06243, N06244, N06251, N06254, N06256, N06258C, N06262, N06263, N06265, N06265A, N06265B, N06265C, N06265D, N06265E, N06266, N06266A, N06267, N06268, N06268A, N06269, N06269A, N06273, N06274, N06274A, N06274B, N06274C, N06275, N06275A, N06275B, N06275C, N06276, N06277, N06277A, N06277B, N06282, N06285, N06285B, N06285C, N06290A, N06294, N06294A, N06295, N06298, N06298A, N06298B, N06301A, N06303, N06304, N06308, N06309, N06310A, N06311
Products Sold
Product list #''s 04J50-01 and 04J50-02, catalog # 420200 Lot numbers: N06227, N06175A, N06176, N06179, N06181, N06186, N06188,, N06194, N06195A, N06200A, N06201A, N06201B, N06201C, N06202, N06206, N06206B, N06208, N06208A, N06209, N06222, N06222A, N06222B, N06223, N06227, N06227A, N06227B, N06235, N06235A, N06236A, N06236B, N06237, N06241, N06241A, N06241B, N06243, N06244, N06251, N06254, N06256, N06258C, N06262, N06263, N06265, N06265A, N06265B, N06265C, N06265D, N06265E, N06266, N06266A, N06267, N06268, N06268A, N06269, N06269A, N06273, N06274, N06274A, N06274B, N06274C, N06275, N06275A, N06275B, N06275C, N06276, N06277, N06277A, N06277B, N06282, N06285, N06285B, N06285C, N06290A, N06294, N06294A, N06295, N06298, N06298A, N06298B, N06301A, N06303, N06304, N06308, N06309, N06310A, N06311,
Abbott Point of Care Inc. is recalling i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Poi due to Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (Int. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Customers were notified by letter sent by regular mail on 12/13/2006.
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