Fastect II Drug Screen Dipstick Test MF20

• • 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 ·via K022355, on the same 510(k)

  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 ·via K022355, on the same 510(k)

  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

Methadone IVD, kit, rapid ICT, clinical

Model / Ref / Catalog

MF20

Primary DI / UDI-DI

00816555021045

510(k) Number

K022355 ↗

FDA Product Code

DJR

GMDN Term

Methadone IVD, kit, rapid ICT, clinical

Device Class

Class II

Regulation Number

862.3620

Commercial Distribution

Not in Commercial Distribution

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