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Alcohol Control Materials

FDA product code DKC · Class 1 · Clinical Toxicology

29
Registered devices
2
Adverse events
5
Recalls
11
510(k) clearances

Devices with this code

Alinity — ABBOTT LABORATORIESSerum Control — Chromsystems Instruments + Chemicals GmbHCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESImmunalysis — IMMUNALYSIS CORPCAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Ethyl Alcohol Level 2 Control (300 mg/dL) — HORIBA INSTRUMENTS INCORPORATEDDRI 300 mg/dL Alcohol Control — Microgenics CorporationUrine Control — Chromsystems Instruments + Chemicals GmbHEthyl Alcohol DAU Control, Level 2 Control — LIN-ZHI INTERNATIONAL, INC.CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Ethyl Alcohol Level 1 Control (50 mg/dL) — HORIBA INSTRUMENTS INCORPORATEDUrine Control — Chromsystems Instruments + Chemicals GmbHDRI 50 mg/dL Alcohol Control — Microgenics CorporationImmunalysis — IMMUNALYSIS CORPUrine Control — Chromsystems Instruments + Chemicals GmbHSynchron — Beckman Coulter, Inc.CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 — CAROLINA LIQUID CHEMISTRIES CORPORATIONWHOLE BLOOD ETHANOL CONTROL LEVEL1 — CLINIQA CORPORATIONSerum Control — Chromsystems Instruments + Chemicals GmbHEthyl Alcohol DAU Control, Level 1 Control — LIN-ZHI INTERNATIONAL, INC.

Recent recalls

DateFirmReason
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.