Home / Recalls / Ameditech Inc / Z-3045-2020

Z-3045-2020 Class II Terminated

Recalled by Ameditech Inc — San Diego, CA

Recall Details

Product Type
Devices
Report Date
October 7, 2020
Initiation Date
August 18, 2020
Termination Date
September 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
189,175 units

Product Description

ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR - NI - PH - BL - S.G.", DT14/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300", HT15/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/PCP25/ THC50/OPI2000", HT15A/ ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/PCP25/ THC50/OPI2000 Adulteration Screen for CR - NI - PH - BL - S.G.", PT15/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/OPI300/THC50" DT13A/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr, Ni, pH, BI, S.G.", DT14A "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300 w/ Cr, Ni, pH, Bl, S.G. Finished Devices", DT12A/"ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; PCP25/PPX300 w/ Cr, Ni, pH, BI, S.G.", PT12A/ "ToxCup¿ Drug Screen Cup COC300/MET500/OPI2000/PCP25/THC50 Adulteration Screen for CR - NI - PH - BL - S.G.", PT11A/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR - NI - PH - BL - S.G.", HT30/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET1000/PCP25/THC50/ OPI2000"

Reason for Recall

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.

Distribution Pattern

US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Code Information

ALL Lots Within Expiry

Other recalls by Ameditech Inc

  • Z-3029-2020 Class II — Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS (August 18, 2020)
  • Z-3049-2020 Class II — First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Numb (August 18, 2020)
  • Z-3044-2020 Class II — TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Dru (August 18, 2020)
  • Z-3051-2020 Class II — Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 10 (August 18, 2020)
  • Z-3047-2020 Class II — First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B (August 18, 2020)
  • Z-3043-2020 Class II — QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Dru (August 18, 2020)
  • Z-3036-2020 Class II — ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / (August 18, 2020)
  • Z-3041-2020 Class II — Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): (August 18, 2020)
  • Z-3042-2020 Class II — ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScre (August 18, 2020)
  • Z-3032-2020 Class II — CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDD (August 18, 2020)