CLASS III Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

QuickTox 5 Panel Drug Screen DipCard recalled by Ameditech

Ameditech is recalling QuickTox 5 Panel Drug Screen DipCard, distributed in 13 states. The recall was initiated on 15 Feb 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCatalog Number: QT11 Lot Number: 188787

Quantity recalled3400 units (136 kits)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0692-2020
FDA event ID: 84239
Recalling firm: Ameditech, San Diego, CA
Classification: Class III
Status: Terminated
Recall initiated: 15 Feb 2019
FDA classified: 17 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Feb 2019	Recall initiated by company
17 Dec 2019	Classified by FDA	+305 days
25 Dec 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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)

Product as listed by the FDA

QuickTox 5 Panel Drug Screen DipCard

Where it was distributed

US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None

Arizona California Florida Georgia Kansas Louisiana Michigan Missouri Mississippi North Carolina Oklahoma Tennessee Texas

Questions about this recall

Why was it recalled?

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)

Which lots are affected?

Catalog Number: QT11 Lot Number: 188787

Where was it sold?

US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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