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.
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 constitutes a risk of harm where injury has not yet been reported.
Plain-English summary
Cardinal Health Inc. is recalling B-Hydroxybutyrate LiquiColor (Item code CH2440058), a product used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma. The recall is limited to Lot 193462.
The recall was initiated because three products requiring refrigerated storage were incorrectly stored outside of approved temperature ranges. 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 providers should stop using the affected lot and contact Cardinal Health for further instructions.
The recalled product
- Product
- B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
- 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 193462
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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