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Terminated

VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

FDA Recall Z-1873-2008 · Posted 2008-09-17

Recalling FirmSun Biomedical Laboratories, Inc.
Recall StatusTerminated
Product CodeDJR
Date Initiated2008-05-28
Date Terminated2009-06-10
Product Quantity330 kits of product VIX-OXD-Dip 07-081-1-257; 1 kits of Vix-OXD-07-018-275

Reason for Recall

Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

Firm 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.

Root Cause

Other

Distribution Pattern

Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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