Beta-Hydroxybutyrate Diagnostic Reagent Recalled for Stability Degradation
Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as Class III. No illnesses, injuries, or reported test failures are documented in the source text. The hazard is potential unreliability of diagnostic results due to reagent degradation, which is theoretical with no actual harm reported.
Plain-English summary
Stanbio Laboratory, LP is recalling Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled), an in vitro diagnostic reagent used in laboratory testing. The product is identified by Lot Number 158894 and Catalog Number 2441-050U, with approximately 200 units distributed.
The recall was issued due to deterioration in the stability of the reagent. This degradation has resulted in lower than expected or out-of-range Quality Control values, which could compromise the reliability of diagnostic test results.
The affected product has been distributed worldwide, including throughout the United States and internationally to Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Vietnam.
The recalled product
- Product
- Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
- Manufacturer
- Stanbio Laboratory, LP
- Affected units
- 200
Distribution
Part of a larger recall action
This product is one of 5 recalled by Stanbio Laboratory, LP 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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