Kamiya Biomedical Recalls K-Assay Multi-Analyte Calibrator Due to Incorrect Values
Kamiya Biomedical is recalling specific lots of the K-Assay Multi-Analyte Calibrator because the Alpha-1 Antitrypsin (AlAT) values listed in the package insert were incorrect.
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 hazard is a labeling error (incorrect calibrator values) which is a minor labeling error that could impact test accuracy but does not present an immediate risk of serious injury or death.
Plain-English summary
Kamiya Biomedical Company, LLC is recalling 1,398 units of the K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C. The recall involves specific lot numbers: N653, N654, D755, D647, F648, F649, G650, J651, and L652. The product is an in vitro diagnostic (IVD) calibrator intended for the calibration of various immunoturbidimetric assays, including Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, IgA, IgG, IgM, and Transferrin.
The recall was initiated because the Alpha-1 Antitrypsin (AlAT) calibrator values provided in the package insert for lot D755, lot N653, and lot N654 were not correct. This labeling error could affect the accuracy of the calibrator for those specific analytes.
The affected units were distributed worldwide, including in the United States (FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA) and internationally to Tunisia, the Czech Republic, Taiwan, the Dominican Republic, Switzerland, China, and Jamaica. Users of the product should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4…
- Manufacturer
- Kamiya Biomedical Company, LLC
- Hazard
- Affected units
- 1,398
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 (9)
- Lot Numbers: N653
- N654
- D755
- D647
- F648
- F649
- G650
- J651
- L652
Distribution
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