Cardinal Health Inc.: Medical Device Recall in 2020 - (Recall #: Z-2050-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 20, 2020

Date Posted: May 27, 2020

Recall Number: Z-2050-2020

Event ID: 85509

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot KN00146

Distribution Pattern:

US Nationwide distribution NC, KS, and AL.

Voluntary or Mandated:

Voluntary: Firm initiated