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Terminated

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

FDA Recall Z-1329-2013 · Posted 2013-05-16

Recalling FirmMedtox Diagnostics Inc
Recall StatusTerminated
Product CodeDIO
Date Initiated2013-04-05
Date Terminated2013-09-12
Product Quantity221,625

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.

Firm Action

MEDTOX issued "URGENT MEDICAL DEVICE RECALL" letters dated April 3, 2013 to consignees informing them of the recall. The letter requested that they examine their inventory and immediately discontinue all use and distribution of the affected lots. The letter also requested that they immediately inform clinicians of the recall at the testing sites that have utilized the recall product. The letter also included a Customer Verification Form which was to be returned.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution: USA (nationwide) and in the country of: Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080635MEDTOXSCANMedtox Diagnostics, Inc. · 2009-02-13

Official Source

View FDA Recall →

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

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