Recall Z-0301-2016— Ameditech Inc
Class II · Terminated
Class II FDA medical device recall by Ameditech Inc, initiated 2015-10-20, terminated 2016-11-09. It names 3 FDA 510(k) clearances: K113501, K113046, K052115. Product: 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.. Reason: Ameditech is recalling drug abuse tests because they have shown reduced reactivity..
- Recalling firm
- Ameditech Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-20
- Terminated
- 2016-11-09
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K113501 — AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
- K113046 — AMEDITECH IMMUTEST MILTI-DRUG SCREEN
- K052115 — FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
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
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Reason for recall
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.