ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
Reported: December 30, 2015 Initiated: November 16, 2015 #Z-0539-2016
Product Description
ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
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.
Details
- Recalling Firm
- Ameditech Inc
- Units Affected
- 743 kits
- Distribution
- Nationwide Distribution.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W. Recalled by Ameditech Inc. Units affected: 743 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Low. Recall number: Z-0539-2016.
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