Recall Z-0418-2018— Alere San Diego, Inc.

Name: FDA recall Z-0418-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-14

Class II · Completed

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2017-11-14. It names one FDA 510(k) clearance: K973784. 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.. Reason: The recalled lots have demonstrated unexpected false positive THC results..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Completed
Initiated: 2017-11-14
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K973784 — TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTSBiosite Incorporated·cleared 1997-12-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The recalled lots have demonstrated unexpected false positive THC results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.