Fastect II Drug Screen Dipstick Test MF25

• 2 recalls, same reason

  • Terminated Z-3029-2020 FDA Class II ·initiated 18 Aug 2020 ·via K082508, on the same 510(k)
  • Terminated Z-3030-2020 FDA Class II ·initiated 18 Aug 2020 ·via K082508, 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

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

Model / Ref / Catalog

MF25

Primary DI / UDI-DI

00816555021083

510(k) Number

K082508 ↗

FDA Product Code

DJG

GMDN Term

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

Device Class

Class II

Regulation Number

862.3650

Commercial Distribution

Not in Commercial Distribution

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