Recall Z-3045-2020— Ameditech Inc
Class II · Terminated
Class II FDA medical device recall by Ameditech Inc, initiated 2020-08-18, terminated 2024-09-30. It names 2 FDA 510(k) clearances: K122633, K032057. Product: 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: 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..
- Recalling firm
- Ameditech Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-18
- Terminated
- 2024-09-30
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.