ToxCup Drug Screen Cup DT10A

• 8 recalls, same reason

  • Terminated Z-3047-2020 FDA Class II ·initiated 18 Aug 2020
  • Terminated Z-3033-2020 FDA Class II ·initiated 18 Aug 2020
  • Terminated Z-3032-2020 FDA Class II ·initiated 18 Aug 2020
  • Terminated Z-3040-2020 FDA Class II ·initiated 18 Aug 2020
  • Terminated Z-3031-2020 FDA Class II ·initiated 18 Aug 2020
  • Terminated Z-3035-2020 FDA Class II ·initiated 18 Aug 2020
  • Terminated Z-3039-2020 FDA Class II ·initiated 18 Aug 2020
  • Terminated Z-3045-2020 FDA Class II ·initiated 18 Aug 2020

  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.

Trade Name

ToxCup Drug Screen Cup

Generic Name

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Model / Ref / Catalog

DT10A

Primary DI / UDI-DI

00816555020482

510(k) Number

K122633 ↗

FDA Product Code

JXN, LCM, DJR, DIS, JXM, DKZ, DJC, DJG, DIO, LDJ

GMDN Term

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Device Class

Class II

Regulation Number

862.3700, 862.3620, 862.3150, 862.3170, 862.3100, 862.3610, 862.3650, 862.3250, 862.3870

GUDID distribution status

Not in Commercial Distribution

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