QuickTox 5 Panel Drug Screen DipCard
FDA Recall Z-0692-2020 · Posted 2019-12-17
Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeDJG
Date Initiated2019-02-15
Date Terminated2021-04-28
Product Quantity3400 units (136 kits)
Reason for Recall
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)
Firm 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 customers receiving the notice are asked to complete and return the included "Customer Verification Form" via fax 888-340-4029.
Root Cause
Labeling mix-ups
Distribution Pattern
US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.