FDA Medical Device Recalls (openFDA)
Ameditech Inc: QuickTox 5 Panel Drug Screen DipCard
- Recall number
- Z-0692-2020
- Recalling firm
- Ameditech Inc
- Product
- QuickTox 5 Panel Drug Screen DipCard
- Status
- Terminated
- Initiated
- 2019-02-15
- Posted
- 2019-12-17
- Terminated
- 2021-04-28
- 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 customers receiving the notice are asked to complete and return the included "Customer Verification Form" via fax 888-340-4029.
- Quantity
- 3400 units (136 kits)
- Distribution
- US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
- Lot, serial or model codes
- Catalog Number: QT11 Lot Number: 188787
- 510(k) numbers
- ["K022355"]
- PMA numbers
- not on file
- Product code
- DJG
- Firm FEI
- 3003789989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28