The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1978-2012·Announced 2012-07-18

Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery Area

Abbott Point of Care is recalling i-Stat Portable Clinical 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 2/5 (Moderate).

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, and the hazard involves the device becoming uncomfortably hot, which presents a risk of minor burn injury but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).

Plain-English summary

Abbott Point of Care Inc. is recalling i-Stat Portable Clinical Analyzers, including the Model 200 and Model 300, as well as the Military Kit Portable Clinical Analyzer. 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. The devices are intended for use by trained medical professionals for in vitro testing of whole blood.

The recall covers units with codes 04J48-01 and 215000 across all lots. The distribution pattern is listed as worldwide distribution, including nationwide distribution in the USA. Users should stop using the affected devices and contact Abbott Point of Care for further instructions.

The recalled product

Product
Military Kit 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…
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Diagnostic Equipment
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)

  • Military Kit Portable Clinical Analyzer 04J48-01 215000 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 →

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