ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagn

The recall communication was initiated on June 9, 2011 with Ameditech Inc. forwarding an Urgent Medical Device Recall notification with an attached Verification Form (via phone and written notification) to the affected distributor. The letter provides the distributor with an explanation of the problem identified and actions to be taken. The distributor was required to: cease distribution of the affected lot and provide remaining inventory count to Ameditech; destroy any remaining inventory of these lots and document destruction per site requirements; and ensure that all user of the device have received a copy of the Urgent Medical Device Recall. In addition, the distributor was instructed to complete and return the enclosed Verification Form with in 10 days. For any questions about the information contained in this notice, contact Ameditech at amd.complaint@alere.com or call 858-535-1968.