Z-0692-2020Class III

QuickTox 5 Panel Drug Screen DipCard

Name: Z-0692-2020 QuickTox 5 Panel Drug Screen DipCard
Creator: Ameditech Inc
Published: 2019-02-15
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2019-02-15 / Terminated / root cause: labeling and UDI

FDA source

Ameditech Inc began a recall of QuickTox 5 Panel Drug Screen DipCard on 2019-02-15. FDA classified it as Class III and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0692-2020
Classification: Class III
Status: Terminated
Initiated: 2019-02-15
Posted: 2019-12-17
Terminated: 2021-04-28
Recalling firm: Ameditech, Inc.
Product: QuickTox 5 Panel Drug Screen DipCard
Product code: DJG Enzyme Immunoassay, Opiates
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)
Root cause tag: labeling and UDI
FDA 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 in commerce: 3400 units (136 kits)
Distribution: US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
Product codes and lots: Catalog Number: QT11 Lot Number: 188787

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0692-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0692-2020	Class III	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-17

Product code DJG

K022355Class IIQuicktox Multiple Drug Dipcard Coc/met/thc/amp/pcp/bzo/bar/mtd/tca, Model Qt61Branan Medical Corp. / cleared 2002-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)