FDA Medical Device Recalls (openFDA)
Alere San Diego, Inc.: 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.
- Recall number
- Z-0418-2018
- Recalling firm
- Alere San Diego, Inc.
- 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.
- Status
- Completed
- Initiated
- 2017-11-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- The recalled lots have demonstrated unexpected false positive THC results.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 2940 units
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Japan, Canada
- Lot, serial or model codes
- Lots 403111, 406741, 396588, 398577, 396587
- 510(k) numbers
- ["K973784"]
- PMA numbers
- not on file
- Product code
- DKZ
- Firm FEI
- 1000125596
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28