FDA Device recall Z-2157-2012
I-STAT PT/INR cartridge Abbott Point of Care Inc
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of I-STAT PT/INR cartridge Abbott Point of Care Inc by Abbott Point, citing the i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2157-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-01 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Point |
| Distribution | US |
Product
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.
Reason
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Identifiers
| code_info | List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2157-2012%22
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