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Terminated

Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

FDA Recall Z-1446-2012 · Posted 2012-04-20

Recalling FirmAlere San Diego dba Biosite Innovacon Hemosense Inc
Recall StatusTerminated
Product CodeDJR
Date Initiated2010-03-12
Date Terminated2012-04-23
Product Quantity1,258,002 kits

Reason for Recall

The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.

Firm Action

Biosite sent a "PRODUCT ADVISORY NOTICE" letter dated March 12, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter states that customers may continue to use the product. Customers were instructed to complete and fax an enclosed verification form to Technical Services at 1-858-695-7100. Customers with any questions about the information contained in the notification were instructed to contact Biosite Inc. at (888) 246-7483.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada and European Union.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060791TRIAGE TOX DRUG SCREEN, MODEL 94400Biosite Incorporated · 2006-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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