Z-1329-2013 Class II Terminated
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,