The Recall Desk

FDA (Devices) recall action 87073

Abbott Point Of Care Inc. recalled 2 products on 2021-01-27

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-01-27
Critical
0
Units
—

Why these products were recalled

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

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

1–2 of 2

  • ModerateFDA (Devices)··2021-01-27

    Abbott i-STAT CG8+ Cartridges Recalled for Ionized Calcium Test Inaccuracy

    Abbott is recalling i-STAT CG8+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.

    Product
    Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-27

    Abbott i-STAT EG7+ Cartridges Recalled for Ionized Calcium Test Inaccuracy

    Abbott Point Of Care Inc. is recalling i-STAT EG7+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.

    Product
    Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
    Category
    Distribution
    0 states