FDAFDA · Food and drugs·Recall number Z-1329-2013
PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
Published May 22, 2013 · Recall initiated: April 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtox Diagnostics Inc
- Distributor
- Worldwide distribution: USA (nationwide) and in the country of: Canada.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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