The Recall Desk

FDA (Devices) recall action 62319

Abbott Point Of Care Inc. recalled 6 products on 2012-07-18

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2012-07-18
Critical
0
Units
—

Why these products were recalled

Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • HighFDA (Devices)··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.

    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 of
    Category
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    0 states
  • ModerateFDA (Devices)··2012-07-18

    Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery

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

    Product
    i-Stat 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 vitro quantit
    Category
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    0 states
  • HighFDA (Devices)··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.

    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 arteria
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    Distribution
    0 states
  • ModerateFDA (Devices)··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.

    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 vitro
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    Distribution
    0 states
  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    0 states