Recall Z-0533-2016— Ameditech Inc
Class III · Terminated
Class III FDA medical device recall by Ameditech Inc, initiated 2015-11-16, terminated 2016-11-09. FDA's recall record names no specific 510(k) clearance for this event. Product: ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300. 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
Product description
ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300
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.