Z-1329-2013 Class II Terminated
FDA device recall Z-1329-2013 was initiated by Medtox Diagnostics Inc on April 5, 2013 and is designated Class II. 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. The recall status is terminated (terminated September 12, 2013). Affected quantity: 221,625.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- April 5, 2013
- Termination Date
- September 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 221,625
Product Description
PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
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.
Distribution Pattern
Worldwide distribution: USA (nationwide) and in the country of: Canada.
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,