FDA Device recall Z-1974-2012
i-Stat Portable Clinical Analyzer
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of i-Stat Portable Clinical Analyzer by Abbott Point, citing some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1974-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-08 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Point |
| Distribution | US |
Product
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
Reason
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Identifiers
| code_info | i-Stat Portable Clinical Analyzer 06F16-02 210000 210001 210002 210003 All lots |
|---|
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-1974-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.