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Recall Observatory FDA recall evidence

Device 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.

Z-0418-2018

November 14, 2017

Class II

Product summary

Firm
Alere San Diego, Inc.
Event
Event 78608
Status
Completed
Classification
Class II
Quantity
2940 units
Official record key
device-enforcement:Z-0418-2018

Official wording

Reason: The recalled lots have demonstrated unexpected false positive THC results.

Code information: Lots 403111, 406741, 396588, 398577, 396587

Distribution pattern: Worldwide distribution - United States Nationwide and the countries of Japan, Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recalled lots have demonstrated unexpected false positive THC results.