Recall Z-3042-2020— Ameditech Inc

Name: FDA recall Z-3042-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-18

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: K113046, K052115. Product: ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO. 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 record

K113046 — AMEDITECH IMMUTEST MILTI-DRUG SCREENAmeditech, Inc.·cleared 2011-11-10
K052115 — FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASYFirst Check Diagnostics, LLC·cleared 2005-12-29

K-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

ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

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.