Recall Z-1329-2013— Medtox Diagnostics Inc

Name: FDA recall Z-1329-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-05

Class II · Terminated

Class II FDA medical device recall by Medtox Diagnostics Inc, initiated 2013-04-05, terminated 2013-09-12. It names one FDA 510(k) clearance: K080635. Product: PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,. Reason: Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing..

Recalling firm: Medtox Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-05
Terminated: 2013-09-12
Firm location: Burlington, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K080635 — MEDTOXSCANMedtox Diagnostics, Inc.·cleared 2009-02-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,

Reason for recall

Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.