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Enzyme Immunoassay, Amphetamine

FDA product code DKZ · Class 2 · Clinical Toxicology

4,008
Registered devices
63
Adverse events
24
Recalls
225
510(k) clearances

Devices with this code

Syva® RapidTest d.a.u.® 10 — Siemens Healthcare Diagnostics Inc.Healgen — Healgen Scientific Limited Liability CompanyT-Cup — WONDFO USA CO., LTD.NOBLE — NOBLE MEDICAL INCPreview — WONDFO USA CO., LTD.INSTA-SCREEN-2TM Cup — NOBLE MEDICAL INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.DOA 5 PANEL TEST — RAPID DIAGNOSTICS INCAlere iScreen Dx — Instant Technologies, Inc.BluRapids™ — MERCEDES MEDICAL, LLCDrugSmart Cup 13 — CHEMTRON BIOTECH INCSyva® Emit® II Plus Ecstasy Assay — Siemens Healthcare Diagnostics Inc.STATCUP® II — MICRO DISTRIBUTING, L.CHealgen — Healgen Scientific Limited Liability CompanyDrugSmart Cup — CHEMTRON BIOTECH INCHigh Sensitivity — Alere San Diego, Inc.Advin Multi-Drug Screen Test — ADVIN BIOTECH, INC.NOBLE — NOBLE MEDICAL INCINCUP — AMERICAN BIO MEDICA CORPORATIONDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT ST312 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.Advin Multi-Drug Screen Test with SVT — ADVIN BIOTECH, INC.

Recent recalls

DateFirmReason
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
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
2017-11-14Alere San Diego, Inc.The recalled lots have demonstrated unexpected false positive THC results.
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on
2013-07-29Sarken, Inc.These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of
2013-07-29Sarken, Inc.These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of

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