FDA Medical Device Recalls (openFDA)
Kamiya Biomedical Company: K-Assay Lp(a) Control
- Recall number
- Z-0940-04
- Recalling firm
- Kamiya Biomedical Company
- Product
- K-Assay Lp(a) Control
- Status
- Terminated
- Initiated
- 2004-03-29
- Posted
- 2004-07-20
- Terminated
- 2004-07-09
- Reason
- Assay result not consistent with the assigned control value
- Root cause
- Other
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Lot D407
- 510(k) numbers
- ["K023853"]
- PMA numbers
- not on file
- Product code
- DFC
- Firm FEI
- 2084025
- Firm city
- Seattle
- 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