K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
FDA device recall Z-0271-2023 · posted 2022-11-21 · Open, Classified
Recall details
- Recalling firm
- Kamiya Biomedical Company, LLC
- Reason for recall
- IgA Reagent may start showing cloudiness over time, which can affect assay performance.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CFF
- Quantity affected
- 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.
- Date initiated
- 2022-09-28
- Date posted
- 2022-11-21
- Location
- Tukwila, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| K-ASSAY IGA (K993213) | Kamiya Biomedical Co. | 1999-11-23 |