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Z-3032-2020 Class II Terminated

Recalled by Ameditech Inc — San Diego, CA

FDA device recall Z-3032-2020 was initiated by Ameditech Inc on August 18, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 30, 2024). Affected quantity: 120, 150.

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
120, 150

Product Description

CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-13 /"CLIA Waived" Inc. Single Drug Dipstick Test OPI300, X07-CLIA-SDDT-25/"CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-12-RDTC-BUP-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-14-RDTC-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-RDDT-70/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-RDDT-52/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ BZO300/BAR300/MTD300/BUPG10/OXY100", X07-CLIA-RDDT-70/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-RDDT-70/"CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G., X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G., X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.". X07-CLIA-12-RDTC-BUP-A "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-14-RDTC-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", CLIA-14-RDTC-A / "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG"

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-3037-2020 Class II — MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP30 (August 18, 2020)
  • Z-3046-2020 Class II — First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B (August 18, 2020)
  • Z-3051-2020 Class II — Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 10 (August 18, 2020)
  • 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-3042-2020 Class II — ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScre (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-3033-2020 Class II — Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): (August 18, 2020)
  • Z-3047-2020 Class II — First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B (August 18, 2020)
  • Z-3039-2020 Class II — Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 St (August 18, 2020)

FDA data resources