K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 recallZ-0271-2023 · Kamiya Biomedical Company, LLC · initiated Sep 28, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kamiya Biomedical Company, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0271-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 28, 2022
- Posted by the FDA
- Nov 21, 2022
- Recalling firm
- Kamiya Biomedical Company, LLC
- Quantity
- 165
- Product code
- CFF
- FDA submissions
- K993213
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
Product description
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Code information (models, lots, serial numbers)
UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- K-ASSAY® IgA Reagent KAI-013Kamiya Biomedical Company, LLC · Immunoelectrophoretic, Immunoglobulins, (G, A, M)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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