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U.S. Department of Health and Human Services

Class 2 Device Recall Triage Drugs of Abuse Panel Plus TCA

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  Class 2 Device Recall Triage Drugs of Abuse Panel Plus TCA see related information
Date Initiated by Firm July 01, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on April 04, 2012
Recall Number Z-0521-2012
Recall Event ID 60519
510(K)Number K973784  
Product Classification Enzyme immunoassay, amphetamine - Product Code DKZ
Product Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000

An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.
Code Information Lots 235991 and 238928.
Recalling Firm/
Manufacturer		 Alere San Diego
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A recall communication was initiated on July 1, 2011 with Alere San Diego forwarding a Product Notification and a Verification Form (via fax, e-mail or direct mail) to all their customers who purchased the Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 9200, Lots 235991 and 238928. The letter provides the customers with an explanation of the problem identified and an action to be taken. The firm reminds customers that clinical consideration and professional judgment must be applied to any test result. Customers were instructed to retain the Product Notification letter for their records as documentation that they have received the information and to ensure that all users have a copy. Alere will replace the lots at the customer's request. As the customers complete the fax back form, they were instructed to indicate whether they wish to replace the affected product. Customers were instructed to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. If customers have any further questions or need to report any concerns they have about the Triage Drugs of Abuse Plus TCA performance, they were instructed to contact Technical Services at (877) 308-8287 or by e-mail at techservice@alere.com.
Quantity in Commerce 997 total kits
Distribution Worldwide Distribution -- US and to 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 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 = DKZ and Original Applicant = BIOSITE INCORPORATED
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