Z-1874-2008

VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual...

Name: Z-1874-2008 VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual...
Creator: Sun Biomedical Laboratories, Inc.
Published: 2008-05-28
License: https://open.fda.gov/license/

Sun Biomedical Laboratories, Inc. / initiated 2008-05-28 / Terminated

FDA source

Sun Biomedical Laboratories, Inc. began a recall of VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs... on 2008-05-28. The reason FDA records is "Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1874-2008
Status: Terminated
Initiated: 2008-05-28
Posted: 2008-09-17
Terminated: 2009-06-10
Recalling firm: Sun Biomedical Laboratories, Inc.
Product: VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Product code: JXN Enzyme Immunoassay, Propoxyphene
Reason for recall: Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
FDA 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 in commerce: 25 kits
Distribution: Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
Product codes and lots: Sun Biomedical Part #: 15-2017, lot number: Vis-PPX Dip 07-094-1-85.

Product code JXN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)