Recall Z-1542-2018 ยท LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
Ameditech Inc
Alere iScreen Dx Urine Drug Screen Card
| Date | Dec 15, 2017 |
| Status | Terminated |
| Reason | The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box. |
| Root cause | Labeling Change Control |
| Action | Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions. |
| Quantity | 828 kits (20,700 devices) |
| Distribution | Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 Branan Medical Corp., Jul 30, 2002 |