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Recall Observatory FDA recall evidence

Device product

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

Z-1329-2013

April 05, 2013

Class II

Product summary

Firm
Medtox Diagnostics Inc
Event
Event 64800
Status
Terminated
Classification
Class II
Quantity
221,625
Official record key
device-enforcement:Z-1329-2013

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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