FDA Medical Device Recalls (openFDA)
Kamiya Biomedical Company, LLC: K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
- Recall number
- Z-0271-2023
- Recalling firm
- Kamiya Biomedical Company, LLC
- Product
- K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
- Status
- Open, Classified
- Initiated
- 2022-09-28
- Posted
- 2022-11-21
- Terminated
- not on file
- Reason
- IgA Reagent may start showing cloudiness over time, which can affect assay performance.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 165
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
- Lot, serial or model codes
- UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30
- 510(k) numbers
- ["K993213"]
- PMA numbers
- not on file
- Product code
- CFF
- Firm FEI
- 2084025
- Firm city
- Tukwila
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28