The Recall Desk
ModerateFDA (Devices)·Z-1975-2012·Announced 2012-07-18

Abbott i-Stat Analyzers Recalled for Excessive Heat in Battery Area

Abbott Point of Care is recalling i-Stat Analyzers because they can become uncomfortably hot to touch in the battery area.

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 hazard involves the device becoming 'uncomfortably hot' without reports of injury or burns, fitting the criteria for a moderate risk or precautionary recall.

Plain-English summary

Abbott Point of Care Inc. is recalling specific i-Stat Analyzers, including the Fuso Analyzer 300F and i-Stat Model 200 and 300. The recall is an extension of a previous action.

The recall is being issued because some of these analyzers become uncomfortably hot to touch in the area of the battery. The affected units were distributed worldwide, including nationwide in the United States.

Consumers and healthcare facilities should stop using the affected i-Stat Analyzers and contact Abbott Point of Care for instructions on how to proceed.

The recalled product

Product
Fuso Analyzer 300F; 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 arte
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Point-of-Care Testing
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)

  • FUSO Analyzer 300F 310003 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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Abbott Point Of Care Inc.

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Same hazard · excessive heat

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