K-Assay Lp(a) Control
FDA device recall Z-0940-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Kamiya Biomedical Company
- Reason for recall
- Assay result not consistent with the assigned control value
- Action taken
- On 3/30/04 customers were faxed a letter and mailed a letter. The letter advises of the problem, requests the customer to discontinue using product, and requests return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DFC
- Quantity affected
- 16
- Distribution
- The firm distributed product to 3 distributors, 1 each in CA, PA, and MN; and 2 labs, 1 each in GA and MI.
- Date initiated
- 2004-03-29
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-09
- Location
- Seattle, 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 LP(A) CONTROLS (K023853) | Kamiya Biomedical Co. | 2002-12-13 |