The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1977-2012·Announced 2012-07-18

Abbott i-Stat Analyzer Recall for Excessive Heat in Battery Area

Abbott Point of Care is recalling i-Stat Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.

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 (excessive heat) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Abbott Point of Care Inc. is recalling i-Stat Analyzers, including the 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 quantification of whole blood parameters.

The recall covers specific units identified by code 04J48-201-1069 and 215001-217. 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
i-STAT1 Abaxis 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…
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)

  • Military Kit iStat1 04J48-201 215001 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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