Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery
Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is described as the device becoming 'uncomfortably hot to touch,' which presents a potential risk of minor burn injury but does not meet the criteria for Severe (4) as there are no reports of hospitalization or significant injury in the source text.
Plain-English summary
Abbott Point of Care Inc. is recalling i-Stat Portable Clinical Analyzers, including Model 200 and Model 300, due to a safety concern. The recall is an extension of a previous action.
The affected devices may become uncomfortably hot to touch in the area of the battery. The i-Stat analyzers are intended for use by trained medical professionals for in vitro quantitative analysis of whole blood.
The recall covers specific unit ranges: 06F16-02-1295, 210000-1076, 210001-447, 210002-5359, and 210003-9051. The products were distributed worldwide, including nationwide in the United States. Users should stop using the affected devices and contact Abbott Point of Care for instructions on replacement or repair.
The recalled product
- 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 quantit
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Abbott Point Of Care Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Abbott Point Of Care Inc.
See all →- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results
FDA (Devices) · 2026-05-06
- Highi-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results
FDA (Devices) · 2026-05-06
- ModerateBlood gas CG8+ cartridges recalled for lacking updated premarket clearance
FDA (Devices) · 2025-09-24
- ModerateBlood gas EG6+ cartridges recalled for lacking updated premarket clearance
FDA (Devices) · 2025-09-24
Same hazard · overheating
See all →- HighGentherm Medical Recalls Blanketrol III Thermal Regulating Systems
FDA (Devices) · 2026-08-26
- HighGentherm Medical Recalls Innercool Coolblue Console Due to Overheating Risk
FDA (Devices) · 2026-08-26
- ModerateGentherm Medical Recalls Blanketrol II Thermal Regulating Systems
FDA (Devices) · 2026-08-26
- Severe
- SevereOXOS Medical Recalls MC2 Portable X-Ray Systems Over Circuit Board Overheating
FDA (Devices) · 2026-08-12