Diagnostic Reagent Stability Issues Lead to Out-of-Range Quality Control Values
Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.
What this means for you
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: This FDA Class III recall involves a diagnostic reagent with stability deterioration affecting quality control results. No illnesses, injuries, or patient harm have been reported. Class III recalls are typically low to moderate severity; the defect is a reliability and accuracy issue rather than an imminent direct safety threat.
Plain-English summary
Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor, an in vitro diagnostic reagent used in laboratory testing. The recall affects 7,108 products with worldwide distribution across the United States and multiple countries.
The reagent has experienced deterioration in chemical stability, resulting in lower than expected or out-of-range quality control values. This indicates the product may not perform reliably during diagnostic testing.
The affected product was distributed to laboratories and diagnostic facilities. The lot numbers associated with this recall are 164312, 161081, 161039, 161031, and 158972. Affected users should contact Stanbio Laboratory for further information and instructions regarding the recall.
The recalled product
- Product
- Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
- Manufacturer
- Stanbio Laboratory, LP
- Hazard
- reagent-deterioration
- inaccurate-results
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 (4)
- 161081
- 161039
- 161031
- 158972
Distribution
Distributed nationwide across the United States.
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