FDAClass IIIDecember 30, 2015

iCup DX 12 Panel w/ Adulterant recall

iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023

Why was iCup DX 12 Panel w/ Adulterant 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

143345 143442 151537 152163 152334 152674 152697 153075 153127 153216 153390 153499 153634

Product
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
Recalling firm
Ameditech Inc
Quantity
9,566 kits
Distribution
Nationwide Distribution.
Recall date
December 30, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls