FDA Medical Device Recalls (openFDA)
Varian, Inc.: On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label
- Recall number
- Z-1202-03
- Recalling firm
- Varian, Inc.
- Product
- On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label
- Status
- Terminated
- Initiated
- 2003-07-18
- Posted
- 2003-09-12
- Terminated
- 2004-05-17
- Reason
- Stability in question.
- Root cause
- Other
- Action
- Recall letter was sent on July 18, 2003 which instructs to stop using affected product and return it for free replacement.
- Quantity
- 11847 kits (50 units/kit)
- Distribution
- Nationwide
- Lot, serial or model codes
- None given.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DML
- Firm FEI
- 2026835
- Firm city
- Lake Forest
- 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