Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-0418-2018

U.S. FDA — Device Enforcement · United States · 2017-11-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0418-2018
Date of alert: 2017-11-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alere San Diego, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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