The Recall Desk

FDA (Devices) recall action 62533

Abbott Point Of Care Inc. recalled 3 products on 2012-08-15

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2012-08-15
Critical
0
Units
—

Why these products were recalled

The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2012-08-15

    Abbott i-Stat cTnl Cartridges Recalled Due to Atmospheric Pressure Effects

    Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges because atmospheric pressure affects the frequency of suppressed results.

    Product
    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2012-08-15

    Abbott i-Stat BNP Cartridges Recalled for Atmospheric Pressure Interference

    Abbott Point of Care Inc. is recalling i-Stat BNP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting heart failure diagnosis.

    Product
    i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2012-08-15

    Abbott i-Stat CK-MP Cartridges Recalled for Atmospheric Pressure Interference

    Abbott Point of Care Inc. is recalling i-Stat CK-MP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting the diagnosis of myocardial infarction.

    Product
    i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of…
    Category
    Distribution
    3 states