K-ASSAY IgA Immunoturbidimetric Assay reagent recalled for cloudiness affecting test performance
Kamiya Biomedical's K-ASSAY IgA Immunoturbidimetric Assay reagent is being recalled due to cloudiness that may develop over time and affect assay performance, potentially impacting test accuracy.
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: The product is a Class II medical device with no reported illnesses, injuries, or hospitalizations. However, this is a diagnostic reagent where performance degradation from cloudiness could lead to misdiagnosis, making it a risk-of-harm product without yet-reported injury, which meets the criteria for High severity.
Plain-English summary
Kamiya Biomedical Company, LLC is recalling the K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013, a diagnostic reagent used in laboratory immunoturbidimetric assays. The recall was initiated because the IgA reagent may develop cloudiness over time, which can negatively affect assay performance and the accuracy of diagnostic test results.
This Class II recall affects 165 units distributed nationwide in Florida, North Carolina, Texas, Tennessee, Pennsylvania, California, New York, Illinois, and Massachusetts, as well as in the Czech Republic. The affected lots are H180 (expiration 2023-01-31), K181 (expiration 2023-03-31), N182 (expiration 2023-06-30), and D283 (expiration 2023-09-30).
Laboratories and healthcare facilities that have received this product should discontinue use of the affected lots immediately. Contact Kamiya Biomedical Company, LLC for guidance on product return and replacement. Any diagnostic results from affected lots should be reviewed to determine if retesting is necessary.
The recalled product
- Product
- K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
- Manufacturer
- Kamiya Biomedical Company, LLC
- Hazard
- reagent-degradation
- assay-malfunction
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 (5)
- UDI-DI: 00816426020092
- Lot/ Expiration Date: H180/ 2023-01-31
- K181/ 2023-03-31
- N182/ 2023-06-30
- D283/ 2023-09-30
Distribution
Distributed nationwide across the United States.
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