—#177823

Product

QuickTox 5 Panel Drug Screen DipCard

FDA product code: DJG — Enzyme Immunoassay, Opiates
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K022355
Affected lot / code info: Catalog Number: QT11 Lot Number: 188787

Why it was 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)

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Ameditech Inc
Address: 9940 Mesa Rim Rd, San Diego, California 92121-2910

Distribution

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

Timeline

Recall initiated: 2019-02-15
Posted by FDA: 2019-12-17
Terminated: 2021-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177823. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.