Recall Z-0492-2016— Ameditech Inc
Class III · Terminated
Class III FDA medical device recall by Ameditech Inc, initiated 2015-11-16, terminated 2016-11-09. It names 3 FDA 510(k) clearances: K113501, K113046, K052115. Product: DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5. Reason: Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide..
- Recalling firm
- Ameditech Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-11-16
- 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
DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5
Reason for recall
Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
Data sourced from openFDA. This site is unofficial and independent of the FDA.