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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source explicitly states that using the products may result in misdiagnosis, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health Inc. is recalling Alere Professional Urine Drug Controls, Item code 88010, Lot KN00146. The recall is due to the products being incorrectly stored outside of approved temperature ranges, despite requiring refrigerated storage conditions.
The use of these temperature-abused products may result in the misdiagnosis of a patient. The affected products were distributed nationwide in North Carolina, Kansas, and Alabama.
Consumers and healthcare facilities should stop using the affected lot and contact Cardinal Health Inc. for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Cardinal Health Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot KN00146
Distribution
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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