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.
FDA Recall Z-0418-2018 · Posted None
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Recalling FirmAlere San Diego, Inc.
Recall StatusCompleted
Product CodeDKZ
Date Initiated2017-11-14
Product Quantity2940 units
Reason for Recall
The recalled lots have demonstrated unexpected false positive THC results.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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