In Vitro Diagnostic Reagent Recalled for Reagent Stability Deterioration
Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.
What this means for you
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: This is a diagnostic reagent recall where stability deterioration has caused quality control failures. Although no illnesses or injuries have been reported, the loss of accuracy in a Beta-Hydroxybutyrate diagnostic test represents a risk-of-harm situation where laboratory test results may be unreliable, potentially affecting diagnosis of serious metabolic conditions.
Plain-English summary
Stanbio Laboratory, LP is recalling Synchron CX/DX/LX Beta-Hydroxybutyrate in vitro diagnostic reagent. This laboratory diagnostic reagent is used to measure Beta-Hydroxybutyrate levels in patient samples. The affected product includes Catalog Number B2440-180 with Lot Number 161020.
The recall was initiated due to deterioration in the stability of the reagent. This deterioration has resulted in quality control values that are lower than expected or outside the expected range. Out-of-range quality control readings indicate the test may not be performing as intended and could affect the accuracy of diagnostic results.
The product was distributed nationwide throughout the United States, as well as to international locations including Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Vietnam.
The recalled product
- Product
- Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Manufacturer
- Stanbio Laboratory, LP
- Hazard
- reagent-degradation
- quality-control-failure
Distribution
Distributed nationwide across the United States.
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