Fastect II Drug Screen Dipstick Test MF21

• • Terminated Z-3034-2020 FDA Class II ·initiated 18 Aug 2020 ·via K022355, on the same 510(k)

  Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

• • Terminated Z-0692-2020 FDA Class III ·initiated 15 Feb 2019 ·via K022355, on the same 510(k)

  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)

• • Terminated Z-1542-2018 FDA Class III ·initiated 15 Dec 2017

  The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.

• • Terminated Z-3084-2017 FDA Class III ·initiated 26 Jun 2017

  The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Trade Name

Fastect II Drug Screen Dipstick Test

Generic Name

Tricyclic antidepressant IVD, kit, rapid ICT, clinical

Model / Ref / Catalog

MF21

Primary DI / UDI-DI

00816555021052

510(k) Number

K022355 ↗

FDA Product Code

LFH

GMDN Term

Tricyclic antidepressant IVD, kit, rapid ICT, clinical

Device Class

Class II

Regulation Number

862.3910

Commercial Distribution

Not in Commercial Distribution

• Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61

  Class II

  FDA 510(k) K022355 Active Cleared 30 Jul 2002

• Fastect Ii Ppx Drug Screen Dipstick, Fastect Ii Drug Screen Dipstick, Quicktox Drug Screen Dipcard

  Class II

  FDA 510(k) K122752 Active Cleared 30 Jan 2013

• Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21

  Class II

  FDA 510(k) K010734 Active Cleared 30 Jul 2001

• Monitect Barbiturates Drug Screen Test

  Class II

  FDA 510(k) K002337 Active Cleared 22 Nov 2000

• Oratect Oral Fluid Drug Screen Devices

  Class II

  FDA 510(k) K103227 Active Cleared 11 Apr 2012

• Branan Medical Corporation Monitect Cocaine Drug Screen Test

  Class II

  FDA 510(k) K002264 Active Cleared 27 Nov 2000

See all devices from Branan Medical Corp. →