Biomerica Recalls Calcitonin ELISA Kits Due to Potential False High Values
Biomerica is recalling Calcitonin ELISA Kits because they may produce false high values. The recall covers 1,062 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II. The source text describes a potential issue with false high values but does not report any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerica is recalling 1,062 units of Calcitonin ELISA Kits, Code No. 7024 and 7024BU. The product is intended for the quantitative determination of Calcitonin in human serum. The recall is due to a potential issue where the kits may produce false high values.
The affected lots are 2041, 2071, 2089, 2124, 2167, 2178, and 2180. These products were distributed worldwide, including in the United States (specifically NH, CA, NJ, and FL) and in Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, the United Kingdom, Egypt, and India.
Users of these kits should stop using the affected lots and contact Biomerica for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
- Manufacturer
- Biomerica
- Affected units
- 1,062
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 (7)
- Lot No. 2041
- 2071
- 2089
- 2124
- 2167
- 2178
- 2180.
Distribution
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