In Vitro Diagnostic Reagent Recalled Due to Stability Deterioration
Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.
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: FDA Class III recall with no reported illnesses or injuries. Reagent stability deterioration affects quality control values—a functional defect likely to be detected during quality control checks in controlled laboratory settings.
Plain-English summary
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX is an in vitro diagnostic reagent manufactured by Stanbio Laboratory, LP. A total of 93 units were distributed worldwide, including throughout the United States and to Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, the United Kingdom, and Vietnam. The affected lot number is 164986.
The reagent has experienced deterioration in stability, resulting in quality control values that are lower than expected or outside the acceptable range. This affects the accuracy and reliability of test results produced using the product.
The recalled product
- Product
- Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
- Manufacturer
- Stanbio Laboratory, LP
- Affected units
- 93
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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