The Recall Desk

FDA (Devices) recall action 72471

Ameditech Inc recalled 20 products on 2015-11-25

The FDA (Devices) publishes a recall like this one as 20 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 20 pages.

Products
20
Announced
2015-11-25
Critical
0
Units
149,975

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–20 of 20

  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls Immutest Drug Screen Cups Due to Reduced Reactivity

    Ameditech is recalling specific Immutest drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and in Australia.

    Product
    Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No.…
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    Distribution
    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls 1 Step 12 Panel Cup Drug Tests

    Ameditech is recalling 787 kits of 1 Step 12 Panel Cup drug tests due to reduced reactivity. The products were distributed in the US and Australia.

    Product
    1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including…
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    0 states
  • HighFDA (Devices)··2015-11-25

    Ameditech Recalls Benzodiazepine Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling EDI BZO Uncut Sheet-Card drug abuse tests because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls iCup Drug Screen Cups Due to Reduced Reactivity

    Ameditech is recalling iCup drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No.…
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    0 states
  • HighFDA (Devices)··2015-11-25

    Ameditech Recalls DrugCheck Waived 12 Panel Cup Tests

    Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.

    Product
    DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls 11 Panel Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling 11 Panel Drug Abuse Tests because they have shown reduced reactivity. The affected products are distributed in the US and Australia.

    Product
    11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Reduced Reactivity

    Ameditech is recalling ArcPoint Labs 10 Panel Dip Screen (OXY) drug tests because they have shown reduced reactivity.

    Product
    ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls ProScreen Drug Panel Tests Due to Reduced Reactivity

    Ameditech is recalling ProScreen drug panel tests because they have shown reduced reactivity. The recall covers 31,530 units distributed in the US and Australia.

    Product
    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls CLIA RDTC 12-Panel Drug Abuse Tests for Reduced Reactivity

    Ameditech is recalling 7,482 units of CLIA RDTC 12-Panel Cup drug abuse tests because they have shown reduced reactivity. The products were distributed in the US and Australia.

    Product
    CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls Thermo Fisher 6 Drug Cassettes Due to Reduced Reactivity

    Ameditech is recalling Thermo Fisher 6 Drug Cassettes because they have shown reduced reactivity. The recall affects 220 units distributed in the US and Australia.

    Product
    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
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    Distribution
    0 states
  • HighFDA (Devices)··2015-11-25

    Ameditech Recalls 11 Panel Dip Cards Due to Reduced Reactivity

    Ameditech is recalling 11 Panel Dip Cards (OPI 2000 and OPI 300) because they have shown reduced reactivity. The recall covers 150 units distributed in the US and Australia.

    Product
    11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of…
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    Distribution
    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls DrugSmart Dip Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling 160 units of DrugSmart Dip drug abuse tests because they have shown reduced reactivity. The affected products were distributed in the US and Australia.

    Product
    DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of…
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    0 states
  • HighFDA (Devices)··2015-11-25

    Ameditech Recalls Micro Screen 6 Panel Drug Abuse Test Cups

    Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.

    Product
    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls DrugSmart Drug Abuse Test Cups Due to Reduced Reactivity

    Ameditech is recalling specific DrugSmart drug abuse test cups because they have shown reduced reactivity. The affected units were distributed in the US and Australia.

    Product
    DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls Premier Clia Waived 12 Panel Tilt Cup Drug Tests

    Ameditech is recalling Premier Clia Waived 12 Panel Tilt Cup drug tests because they have shown reduced reactivity.

    Product
    Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls 6 Panel Drug Detection Cups Due to Reduced Reactivity

    Ameditech is recalling 2,240 units of 6 Panel Cup Body and Lid drug tests because they have shown reduced reactivity.

    Product
    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse…
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    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls DrugSmart 10 Test Cups Due to Reduced Reactivity

    Ameditech is recalling DrugSmart 10 Test Cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
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    Distribution
    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls 10-Panel Pipette Drug Screen Due to Reduced Reactivity

    Ameditech is recalling 10-Panel Pipette Drug Screen tests because they have shown reduced reactivity. The recall affects 200 units distributed in the US and Australia.

    Product
    10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls DrugCheck Pipette 10 Drug Tests Due to Reduced Reactivity

    Ameditech is recalling 70 units of DrugCheck Pipette 10 Drug Tests because they have shown reduced reactivity. The affected tests were distributed in the US and Australia.

    Product
    DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-11-25

    Ameditech Recalls 12-Panel Dip Drug Screens Due to Reduced Reactivity

    Ameditech is recalling 12-Panel Dip Drug Screens with adulterant because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
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    Distribution
    0 states