Recall Z-0692-2020
Ameditech Inc · initiated February 15, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
QuickTox 5 Panel Drug Screen DipCard
Codes / lots: Catalog Number: QT11 Lot Number: 188787
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)
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0692-2020
- Initiated
- February 15, 2019
- Posted by FDA
- December 17, 2019
- Terminated
- April 28, 2021
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Quantity
- 3400 units (136 kits)
- Distribution
- US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
- Recalling firm
- Ameditech Inc, San Diego, CA