Ameditech Recalls
109 recalls on record · October 22, 2014 to October 7, 2020 · Medical Devices
Recalls by year
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17
18
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20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /18
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/ME
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC3
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI200
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug S
Hazard: XXX
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Dru
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500;
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300)
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 wi
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+B
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Pane
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Dr
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS O
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dip
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adultera
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs o
Hazard: 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.
October 7, 2020Medical DevicesFDA
Ameditech Inc recalls Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip
Hazard: 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.
December 25, 2019Medical DevicesFDA
Ameditech Inc recalls QuickTox 5 Panel Drug Screen DipCard
Hazard: Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)
October 31, 2018Medical DevicesFDA
Ameditech Inc recalls Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid de
Hazard: Product was released to market without the adulteration strip included in the product.
May 9, 2018Medical DevicesFDA
Ameditech Inc recalls Alere iScreen Dx Urine Drug Screen Card
Hazard: The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
September 6, 2017Medical DevicesFDA
Ameditech Inc recalls Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 I
Hazard: The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
December 30, 2015Medical DevicesFDA
Ameditech Inc recalls THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
Hazard: 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.
December 30, 2015Medical DevicesFDA
Ameditech Inc recalls THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU
Hazard: 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.
December 30, 2015Medical DevicesFDA
Ameditech Inc recalls RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
Hazard: 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.