Recall Z-0692-2020— Ameditech Inc

Name: FDA recall Z-0692-2020
Creator: U.S. Food and Drug Administration
Published: 2019-02-15

Class III · Terminated

Class III FDA medical device recall by Ameditech Inc, initiated 2019-02-15, terminated 2021-04-28. It names one FDA 510(k) clearance: K022355. Product: QuickTox 5 Panel Drug Screen DipCard. 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).

Recalling firm: Ameditech Inc
Classification: Class III
Status: Terminated
Initiated: 2019-02-15
Terminated: 2021-04-28
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K022355 — QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61Branan Medical Corp.·cleared 2002-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

QuickTox 5 Panel Drug Screen DipCard

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.