The Recall Desk

FDA (Devices) recall action 85509

Cardinal Health Inc. recalled 3 products on 2020-05-27

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
2020-05-27
Critical
0
Units
—

Why these products were recalled

Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2020-05-27

    Cardinal Health Recalls Urine Drug Controls Due to Temperature Abuse

    Cardinal Health is recalling Alere Professional Urine Drug Controls (Lot KN00146) because they were stored outside approved temperature ranges, which may result in patient misdiagnosis.

    Product
    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment p
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2020-05-27

    Cardinal Health Recalls B-Hydroxybutyrate LiquiColor Due to Temperature Abuse

    Cardinal Health is recalling B-Hydroxybutyrate LiquiColor test kits because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
    Category
    Distribution
    3 states