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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 December 15, 2017
Create Date April 28, 2018
Recall Status1 Terminated 3 on February 11, 2019
Recall Number Z-1542-2018
Recall Event ID 79549
510(K)Number K022355  
Product Classification U.V. Spectrometry, tricyclic antidepressant drugs - Product Code LFH
Product Alere iScreen Dx Urine Drug Screen Card
Code Information Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.
Recalling Firm/
Manufacturer		 Ameditech Inc
9940 Mesa Rim Rd
San Diego CA 92121-2910
For Additional Information Contact
858-805-3607
Manufacturer Reason
for Recall		 The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
FDA Determined
Cause 2		 Labeling Change Control
Action Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions.
Quantity in Commerce 828 kits (20,700 devices)
Distribution Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
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.
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