San Diego, CA, United States
Ameditech Inc recalls
4 recalls recorded since 2018, most recently on 18 August 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 August 2020
- Terminated
- 30 September 2024
- Reason
- 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
- US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3050-2020, Z-3039-2020, Z-3036-2020, Z-3051-2020, Z-3044-2020, Z-3035-2020, Z-3047-2020, Z-3033-2020, Z-3045-2020, Z-3040-2020, Z-3048-2020, Z-3043-2020 and 11 more
- First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
- Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished
- ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup
- Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/
- TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G."
- Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
- First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
- Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/
- and 15 more product lines
Terminated Class III Medical devices
- Recall started
- 15 February 2019
- Terminated
- 28 April 2021
- Reason
- 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)
- Distribution
- US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0692-2020
- QuickTox 5 Panel Drug Screen DipCard
Terminated Class III Medical devices
- Recall started
- 15 December 2017
- Terminated
- 11 February 2019
- Reason
- 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
- Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1542-2018
- Alere iScreen Dx Urine Drug Screen Card
Terminated Class III Medical devices
- Recall started
- 30 September 2017
- Terminated
- 6 August 2019
- Reason
- Product was released to market without the adulteration strip included in the product.
- Distribution
- US in the state of California
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0270-2019
- Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step proce
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.