Abbott i-STAT1 Abaxis Analyzer Recalled for Overheating Battery Area
Abbott Point of Care is recalling i-STAT1 Abaxis Analyzers because the battery area can become uncomfortably hot to touch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (burn injury) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott Point of Care Inc. is recalling i-STAT1 Abaxis Analyzers (model 6000-0000-650) due to a safety concern. The recall is an extension of a previous action.
The recall is being issued because some of the analyzers become uncomfortably hot to touch in the area of the battery. This heat presents a potential burn hazard to users.
The affected units were distributed worldwide, including nationwide distribution 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-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- i-Stat1 Abaxis Analyzer 6000-0000 All lots
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.
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