FDA Medical Device Recalls (openFDA)
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 number
- Z-0364-2007
- Recalling firm
- Abbott Point of Care Inc.
- 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
- Status
- Terminated
- Initiated
- 2006-12-12
- Posted
- 2007-01-23
- Terminated
- 2007-08-15
- Reason
- 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.
- Root cause
- Other
- Action
- Customers were notified by letter sent by regular mail on 12/13/2006.
- Quantity
- 14,045 boxes of 24
- Distribution
- Nationwide to hospitals and health care facilities
- Lot, serial or model codes
- 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,
- 510(k) numbers
- ["K020355"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 2245578
- Firm city
- East Windsor
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28