Kamiya Biomedical Company, LLC K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Brand
Kamiya Biomedical Company, LLC
Lot Codes / Batch Numbers
UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
Products Sold
UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
Kamiya Biomedical Company, LLC is recalling K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 due to IgA Reagent may start showing cloudiness over time, which can affect assay performance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Recommended Action
Per FDA guidance
On 9/28/22, recall notices were sent to customers informing them to stop using affected kit lots and to return complete and partially used kits to the recalling firm. Further, if opaque turbidity is observed, or the controls of the affected assay are not within range, do not report the test results. Distributors are asked to contact their customers and to inform them of the recall. Alternately, distributors can send the recalling firm their customer list so the recalling firm can notify the customers directly. Complete and return the customer acknowledgement. The following firm contacts were provided: (206) 575-8068 and quality@k-assay.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026