Recall Z-0692-2020 ยท DJG Enzyme Immunoassay, Opiates
Ameditech Inc
QuickTox 5 Panel Drug Screen DipCard
| Date | Dec 17, 2019 (initiated Feb 15, 2019) |
| Status | Terminated |
| Reason | Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744) |
| Root cause | Labeling mix-ups |
| Action | On February 15, 2019, the firm sent a "FIELD CORRECTIVE ACTION NOTIFICATTION" via email (read receipt requested), and/or via certified mail with delivery tracking to its customers informing them of mixed products, QuickTox 5 Panel Drugs Screen Dipcard, part number QT11 with lot number 188787 containing Alere iScreen Drugs of Abuse Dip Test, part number X11-IS10-22015-DX lot number 188744. Customer are being requested to return the affected products and if products were further distributed customers are to notify those customers and request for return of affected products. In addition, all cus |
| Quantity | 3400 units (136 kits) |
| Distribution | US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None |
| 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 |