Z-0364-2007

i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care...

Name: Z-0364-2007 i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care...
Creator: Abbott Point of Care Inc.
Published: 2006-12-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-12-12 / Terminated

FDA source

Abbott Point of Care Inc. began a recall of 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... on 2006-12-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0364-2007
Status: Terminated
Initiated: 2006-12-12
Posted: 2007-01-23
Terminated: 2007-08-15
Recalling firm: Abbott Medical
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
Product code: GJS Test, Time, Prothrombin
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.
FDA root cause: Other
Action: Customers were notified by letter sent by regular mail on 12/13/2006.
Quantity in commerce: 14,045 boxes of 24
Distribution: Nationwide to hospitals and health care facilities
Product codes and lots: 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,

Product code GJS

K020355Class III-Stat Prothrombin Time TestI-Stat Corporation / cleared 2002-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)