I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott… recallZ-2157-2012 · Abbott Point Of Care Inc. · initiated Mar 1, 2012
Class II Terminated All recalls posted in August 2012
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
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
FDA root cause category: Process control
What the company is doing
Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.
Recall details
- Recall number
- Z-2157-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 1, 2012
- Posted by the FDA
- Aug 8, 2012
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 2,950,296 cartridges US; 156,408 cartridges OUS
- Product code
- GJS
- FDA submissions
- K020355
- Distribution
- Worldwide Distribution -- (USA) nationwide
Product description
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Code information (models, lots, serial numbers)
List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
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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