FDA Medical Device Recalls (openFDA)
Accumetrics Inc: VerifyNow Asprin Assay Kit Part No. 85034
- Recall number
- Z-1018-04
- Recalling firm
- Accumetrics Inc
- Product
- VerifyNow Asprin Assay Kit Part No. 85034
- Status
- Terminated
- Initiated
- 2004-05-10
- Posted
- 2004-07-20
- Terminated
- 2004-09-07
- Reason
- Test results too low in control.
- Root cause
- Other
- Action
- Letters were sent FEDEX on May 10, 2004. Customers were requested to discard the product. Distributors opted to return product. A response form was included to track materials.
- Quantity
- 4500
- Distribution
- Nationwide.
- Lot, serial or model codes
- Assay Device Lot WD0034, Kit Lots W17105, W17140.
- 510(k) numbers
- ["K012701"]
- PMA numbers
- not on file
- Product code
- JOZ
- Firm FEI
- 3001376288
- Firm city
- San Diego
- Firm state
- CA
- 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