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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Brand
Sun Biomedical Laboratories, Inc.
Lot Codes / Batch Numbers
Sun Biomedical Part Numbers: 15-2016, Product lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257.
Products Sold
Sun Biomedical Part Numbers: 15-2016; Product lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257.
Sun Biomedical Laboratories, Inc. is recalling VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color com due to Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026