FDA Device recall Z-0451-2014
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitori…
- FDA Device
- Class II
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class II recall of Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitori… by Abbott Point, citing abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0451-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-28 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Point |
| Distribution | US |
Product
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Reason
Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
Identifiers
| code_info | K020355 List number 04J50-01, 04J50-02; 03P89-24 Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A |
|---|
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-0451-2014%22
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