FDA Medical Device Recalls (openFDA)
Sun Biomedical Laboratories, Inc.: VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
- Recall number
- Z-1873-2008
- Recalling firm
- Sun Biomedical Laboratories, Inc.
- Product
- VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
- Status
- Terminated
- Initiated
- 2008-05-28
- Posted
- 2008-09-17
- Terminated
- 2009-06-10
- Reason
- Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
- Root cause
- Other
- Action
- On May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading "Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388.
- Quantity
- 330 kits of product VIX-OXD-Dip 07-081-1-257; 1 kits of Vix-OXD-07-018-275
- Distribution
- Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
- Lot, serial or model codes
- Sun Biomedical Part Numbers: 15-2016; Product lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DJR
- Firm FEI
- 1000526795
- Firm city
- Blackwood
- Firm state
- NJ
- 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