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First Check 2 Drug Test

by First Check Diagnostic Corp. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643281067555 UDI-DIDate30 Jun 2016ListedStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

86 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-3050-2020 FDA Class II initiated 18 Aug 2020 via K052115, on the same 510(k)
    • Terminated Z-3031-2020 FDA Class II initiated 18 Aug 2020
    • Terminated Z-3046-2020 FDA Class II initiated 18 Aug 2020 via K052115, on the same 510(k)
    • Terminated Z-3048-2020 FDA Class II initiated 18 Aug 2020 via K052115, on the same 510(k)
    • Terminated Z-3049-2020 FDA Class II initiated 18 Aug 2020 via K052115, on the same 510(k)
    • Terminated Z-3042-2020 FDA Class II initiated 18 Aug 2020 via K052115, on the same 510(k)
    • Terminated Z-3036-2020 FDA Class II initiated 18 Aug 2020 via K052115, 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.

  • 58 recalls, same reason

    • Terminated Z-0505-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0536-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0518-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0486-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0522-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0511-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0527-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0539-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0485-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0490-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0516-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0537-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0510-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0493-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0497-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0504-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0530-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0519-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0538-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0494-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0499-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0517-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0521-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0495-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0532-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0531-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0500-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0487-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0512-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0507-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0526-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0488-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0529-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0528-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0484-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0520-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0524-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0491-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0508-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0515-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0534-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0541-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0496-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0535-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0540-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0503-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0489-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0501-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0525-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0506-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0498-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0523-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0542-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0502-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0513-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0509-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0514-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)
    • Terminated Z-0492-2016 FDA Class III initiated 16 Nov 2015 via K052115, on the same 510(k)

    Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

  • 20 recalls, same reason

    • Terminated Z-0302-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0304-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0307-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0298-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0308-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0310-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0314-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0315-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0311-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0306-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0303-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0301-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0309-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0300-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0316-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0305-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0317-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0313-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0312-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)
    • Terminated Z-0299-2016 FDA Class II initiated 20 Oct 2015 via K052115, on the same 510(k)

    Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

    • Terminated Z-0152-2012 FDA Unclassified (pre-2012) initiated 7 Jun 2011 via K052115, on the same 510(k)

    The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics' customers received ProScreen 5-panel cups that contain First Check THC cups. The recalled products are mislabeled. If the USD customer receives the FirstCheck tes, there will be no instructions for use

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

Specification

GUDID

Trade Name
First Check
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Reference
2 Drug Test
Primary DI / UDI-DI
00643281067555
510(k) Number
FDA Product Code
NFY, DIO, LDJ, NFW
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.3250, 862.3870
Commercial Distribution
Not in Commercial Distribution

Related devices

Cleared under the same submission (K052115)

Show all (12)

Properties

  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No