Class 3 Device Recall Alere iScreen Dx Urine Drug Screen Card

• Date Initiated by Firm: June 26, 2017
• Create Date: August 29, 2017
• Recall Status: Terminated on August 06, 2019
• Recall Number: Z-3084-2017
• Recall Event ID: 77702
• 510(K)Number: K022355
• Product Classification: U.V. Spectrometry, tricyclic antidepressant drugs - Product Code LFH
• Product: Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
• Code Information: P/N IS10-DX; Lot No. U0731
• Recalling Firm/ Manufacturer: Ameditech Inc; 9940 Mesa Rim Rd; San Diego CA 92121-2910
• For Additional Information Contact: Kristin Gordon; 858-805-3607
• Manufacturer Reason for Recall: The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
• FDA Determined Cause: Labeling Change Control
• Action: Ameditech, Inc. sent an Medical Device Labeling Correction letter to all affected consignees. Remaining product at the firm was quarantined and will be scrapped. Consignees will be notified of the labeling error with a correction notification. The kit label has been corrected and is available for future product. The firm plans to conduct effectiveness checks based upon receipt of the Label Correction notification by consignees. Firm indicates that no customer action is required, so no formal reply from distributors is necessary. Customers who have not had confirmed receipt of correction notification will be telephoned. For questions regarding this recall call 858-805-3607.
• Quantity in Commerce: 263Kits
• Distribution: Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LFH