i-STAT PT/INR Cartridge recallZ-1996-2010 · Abbott Point of Care Inc. · initiated May 5, 2010
Terminated All recalls posted in July 2010
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
A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.
FDA root cause category: Other
What the company is doing
Urgent recall notifications were sent on May 13 2010. Customers were instructed to discontinue use and to return the identified lots. Additional questions are directed to Abbott Point of Care Technical Support at 800-3668020, Option 1 or your Abbott Point of Care representative.
Recall details
- Recall number
- Z-1996-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 5, 2010
- Posted by the FDA
- Jul 13, 2010
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 44976 in US, 3648 in rest of world.
- Product code
- GJS
- FDA submissions
- K020355
- Distribution
- Worldwide distribution: Argentina, Hong Kong, China, Finland, Greece, India, Portugal, Russian Federation, Saudi Arabia, United Arab Emirates, Italy, Spain, Australia, Germany, UK, Sweden, The Netherlands, France, Canada.
Product description
i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
Code information (models, lots, serial numbers)
Catalog numbers: 04J50-01, 04J50-02. Lot numbers: N09315, exp 4/28/2010; N09323, exp 5/14/2010; N09323A, exp 5/14/2010; N09346A, exp 5/28/2010; S09347, exp 5/28/2010; S09354, exp 6/14/2010; T10009, exp 6/28/2010; T10011, exp 6/28/2010.
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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