FDAClass IIIDecember 30, 2015

ProScreen CLIA Wvd 12 Panel Cup w/Adult recall

ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W

Why was ProScreen CLIA Wvd 12 Panel Cup w/Adult 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?

152171 152216 153103

Product
ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W
Recalling firm
Ameditech Inc
Quantity
1,680 kits
Distribution
Nationwide Distribution.
Recall date
December 30, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls