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.
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: 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
- Affected units
- 7,108
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
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Stanbio Laboratory, LP
See all →- HighBlood Ketone Test Strips Recalled for False Negative Results
FDA (Devices) · 2023-12-13
- HighBreast Milk Analyzer Lacks FDA Validation, Risks Sub-optimal Infant Nutrition
FDA (Devices) · 2022-04-20
- ModerateBeta-Hydroxybutyrate diagnostic reagent recalled due to stability degradation
FDA (Devices) · 2021-08-11
- ModerateIn Vitro Diagnostic Reagent Recalled Due to Stability Deterioration
FDA (Devices) · 2021-08-11
- HighIn Vitro Diagnostic Reagent Recalled for Reagent Stability Deterioration
FDA (Devices) · 2021-08-11
Same hazard · reagent deterioration
See all →- ModerateBinding Site Recalls Optilite C-Reactive Protein Kits Due to Deterioration
FDA (Devices) · 2019-12-18
Similar recalls
- ModerateHydroxybutyrate Test Kits Recalled Due to Improper Storage
FDA (Devices) · 2022-04-20
- HighCardinal Health Recalls B-Hydroxybutyrate LiquiColor Due to Temperature Abuse
FDA (Devices) · 2020-05-27
- ModerateMedical Device Linearity Standards Recalled Due to Improper Storage Controls
FDA (Devices) · 2022-04-20
- ModerateBeckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk
FDA (Devices) · 2023-05-24
- ModerateDiagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift
FDA (Devices) · 2026-09-09
- ModerateStanbio TDM/B-Hydroxybutyrate Controls Recalled Due to Improper Storage Temperature
FDA (Devices) · 2021-12-29