Fastect II Drug Screen Dipstick Test MF23

• • Terminated Z-3034-2020 FDA Class II ·initiated 18 Aug 2020 ·via K030113, 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.

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

Oxycodone IVD, kit, rapid ICT, clinical

Model / Ref / Catalog

MF23

Primary DI / UDI-DI

00816555021076

510(k) Number

K030113 ↗

FDA Product Code

DJG

GMDN Term

Oxycodone IVD, kit, rapid ICT, clinical

Device Class

Class II

Regulation Number

862.3650

Commercial Distribution

Not in Commercial Distribution

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