Medtox Diagnostics Inc: Medical Device Recall in 2013 - (Recall #: Z-1329-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 5, 2013

Date Posted: May 22, 2013

Recall Number: Z-1329-2013

Event ID: 64800

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.

Status: Terminated

Product Quantity: 221,625

Code Information:

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,

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated