Beta-Hydroxybutyrate diagnostic reagent recalled due to stability degradation
Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic 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 reagent stability and quality control issues with no reported deaths, illnesses, or injuries. The hazard of inaccurate diagnostic results is theoretical rather than confirmed, consistent with a precautionary recall.
Plain-English summary
Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents (3,940 units) manufactured by Stanbio Laboratory are being recalled due to deterioration in reagent stability.
The affected reagents have exhibited stability degradation that results in quality control values that are lower than expected or out of range. This may impact the accuracy and reliability of diagnostic test results.
The recalled lot numbers are 166355, 165053, 163944, and 162092. These reagents were distributed nationwide across 32 U.S. states and internationally to Australia, Canada, Chile, Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Vietnam.
Healthcare facilities and laboratories should immediately cease use of the affected lot numbers and contact Stanbio Laboratory or Cardinal Health for instructions regarding replacement or returns.
The recalled product
- Product
- Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Manufacturer
- Stanbio Laboratory, LP
- Affected units
- 3,940
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 (3)
- 165053
- 163944
- 162092
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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