i-STAT PT/INR Cartridge prothrombin time test in vitro… recallZ-0364-2007 · Abbott Point of Care Inc. · initiated Dec 12, 2006
Terminated All recalls posted in January 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Point of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
Customers were notified by letter sent by regular mail on 12/13/2006.
Recall details
- Recall number
- Z-0364-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 12, 2006
- Posted by the FDA
- Jan 23, 2007
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 14,045 boxes of 24
- Product code
- GJS
- FDA submissions
- K020355
- Distribution
- Nationwide to hospitals and health care facilities
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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,
Other devices under the same FDA submission
1 device cleared under K020355 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 03P89-24Abbott Point Of Care Inc. · TEST, TIME, PROTHROMBIN127 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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