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U.S. Department of Health and Human Services

Class 3 Device Recall Alere iScreen Dx Urine Drug Screen Card

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  Class 3 Device Recall Alere iScreen Dx Urine Drug Screen Card see related information
Date Initiated by Firm June 26, 2017
Create Date August 29, 2017
Recall Status1 Terminated 3 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/
Ameditech Inc
9940 Mesa Rim Rd
San Diego CA 92121-2910
For Additional Information Contact Kristin Gordon
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 2
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 and Original Applicant = BRANAN MEDICAL CORP.