Z-1329-2013Class II

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

Name: Z-1329-2013 PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in...
Creator: Medtox Diagnostics Inc
Published: 2013-04-05
License: https://open.fda.gov/license/

MEDTOX Diagnostics, Inc. / initiated 2013-04-05 / Terminated / root cause: manufacturing process

FDA source

Medtox Diagnostics Inc began a recall of PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine on 2013-04-05. FDA classified it as Class II and gives the reason as "Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1329-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-05
Posted: 2013-05-16
Terminated: 2013-09-12
Recalling firm: MEDTOX Diagnostics, Inc.
Product: PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 221,625
Distribution: Worldwide distribution: USA (nationwide) and in the country of: Canada.
Product codes and lots: Part No. 604018 - Lot No. 6821, 6822, 6823, 6824, 6825, 6831, 6832, 6841, 6851, 6852, 6853, 6861, 6862, 6863, 6864, 6865, 6866, 6867, 6868, 6871, 6881, 6891, 6892, 6901, 6902, 6903, 6904, 6911, 6912, 6921, 6922, 6931, 6942; Part No. 604019 - Lot No. 6321, 6331, 6341, 6351; Part No. 604020 - Lot No. 6361, 6371; Part No. 604022 - Lot No. 6551, 6552, 6561, 6562, 6563, 6564, 6571, 6581, 6582, 6583, 6584, 6591, 6592, 6593, 6601, 6602, 6603, 6611, 6612, 6621, 6622, 6623, 6631, 6632, 6641, 6651, 6652, 6661, 6671, 6672, 6681; Part No. 604026 - Lot No. 6041, 6051; Part No. 604028 - Lot No. 6051, 6061, 6071, 6081, 6091,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1329-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1329-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-16

Product code DIO

K080635Class IIMedtoxscanMedtox Diagnostics, Inc. / cleared 2009-02-13

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)