FDA Medical Device Recalls (openFDA)
Drug Free Enterprises Inc: DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
- Recall number
- Z-0239-04
- Recalling firm
- Drug Free Enterprises Inc
- Product
- DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
- Status
- Terminated
- Initiated
- 2003-03-20
- Posted
- 2003-12-18
- Terminated
- 2003-12-17
- Reason
- Lacks professional use labeling and firm name and address.
- Root cause
- Other
- Action
- Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.
- Quantity
- 2800 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- All Codes.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DIO
- Firm FEI
- 3003470018
- Firm city
- Agoura Hills
- 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