ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one

FDA device recall Z-0152-2012 · posted 2011-11-03 · Terminated

Recall details

Recalling firm

Ameditech Inc

Reason for recall

The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics' customers received ProScreen 5-panel cups that contain First Check THC cups. The recalled products are mislabeled. If the USD customer receives the FirstCheck tes, there will be no instructions for use

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

DKZ

Quantity affected

2000 test cups (800 kits)

Distribution

Nationwide Distribution (USA) including the state of Alabama.

Date initiated

2011-06-07

Date posted

2011-11-03

Date terminated

2012-01-18

Location

San Diego, CA

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