Home / Recalls / Ameditech Inc / Z-1542-2018

Z-1542-2018 Class III Terminated

Recalled by Ameditech Inc — San Diego, CA

Recall Details

Product Type
Devices
Report Date
May 9, 2018
Initiation Date
December 15, 2017
Termination Date
February 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
828 kits (20,700 devices)

Product Description

Alere iScreen Dx Urine Drug Screen Card

Reason for Recall

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.

Distribution Pattern

Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.

Code Information

Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.

Other recalls by Ameditech Inc

  • Z-3049-2020 Class II — First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Numb (August 18, 2020)
  • Z-3047-2020 Class II — First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B (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-3042-2020 Class II — ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScre (August 18, 2020)
  • Z-3051-2020 Class II — Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 10 (August 18, 2020)
  • Z-3033-2020 Class II — Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): (August 18, 2020)
  • Z-3043-2020 Class II — QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Dru (August 18, 2020)
  • Z-3034-2020 Class II — Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AM (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-3032-2020 Class II — CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDD (August 18, 2020)