The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1973-2012·Announced 2012-07-18

Abbott i-Stat Analyzers Recalled Due to Excessive Heat in Battery Area

Abbott Point of Care is recalling i-Stat Model 200 and 300 analyzers because they may become uncomfortably hot to touch near the battery.

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 for risk-of-harm products without reported illness.

Plain-English summary

Abbott Point of Care Inc. is recalling i-Stat Model 200 and Model 300 Portable Clinical Analyzers. This action is a recall extension. The devices are intended for use by trained medical professionals for in vitro quantitative analysis of arterial, venous, or capillary whole blood.

The recall is issued because some i-Stat Analyzers become uncomfortably hot to touch in the area of the battery. The source text does not specify the number of affected units, specific lot numbers, or the exact distribution dates, though the distribution is listed as worldwide and nationwide in the USA.

Consumers and healthcare facilities should stop using the affected devices and contact Abbott Point of Care for further instructions. The recall number is Z-1973-2012.

The recalled product

Product
iStat1 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 of…
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Clinical Analyzer
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 (5)

  • 510K K940918 Product Number/List Number 06F16-05
  • 06F16--10
  • 310000
  • 310001
  • 310002 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.

See all →

Same hazard · burn injury

See all →

Similar recalls