Cardinal Health Inc.: 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.

Agency Publication Date: May 20, 2020

Affected Products

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.

Lot KN00146

Lot Numbers:

KN00146

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 prior to vaginal delivery in order to prevent infection of the neonate.

All lots

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

Lot 193462

Lot Numbers:

193462

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85509

Status: Resolved

Manufacturer: Cardinal Health Inc.

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot KN00146

Lot Numbers:

KN00146

All lots

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

Lot 193462

Lot Numbers:

193462