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U.S. Department of Health and Human Services

Class 2 Device Recall Triage Drugs of Abuse Plus TCA 25 Test Kit

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  Class 2 Device Recall Triage Drugs of Abuse Plus TCA 25 Test Kit see related information
Date Initiated by Firm November 14, 2017
Create Date January 26, 2018
Recall Status1 Open3, Classified
Recall Number Z-0418-2018
Recall Event ID 78608
510(K)Number K973784  
Product Classification Enzyme immunoassay, amphetamine - Product Code DKZ
Product Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of
Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box.

Product Usage:
The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.
Code Information Lots 403111, 406741, 396588, 398577, 396587
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact Technical Services
858-805-2000 Ext. 3015
Manufacturer Reason
for Recall		 The recalled lots have demonstrated unexpected false positive THC results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action All primary consignees will be contacted in letter provided via fax, email or direct mail. End users will be instructed to discard any remaining inventory they may have of the affected lots. Alere will provide credit to end users for any remaining unused inventory.
Quantity in Commerce 2940 units
Distribution Worldwide distribution - United States Nationwide and the countries of Japan, Canada
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DKZ and Original Applicant = BIOSITE INCORPORATED
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