FDA Medical Device Recalls (openFDA)
Alere San Diego: Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.
- Recall number
- Z-0521-2012
- Recalling firm
- Alere San Diego
- Product
- Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.
- Status
- Terminated
- Initiated
- 2011-07-01
- Posted
- 2012-01-11
- Terminated
- 2012-04-04
- Reason
- The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928.
- Root cause
- Nonconforming Material/Component
- Action
- A recall communication was initiated on July 1, 2011 with Alere San Diego forwarding a Product Notification and a Verification Form (via fax, e-mail or direct mail) to all their customers who purchased the Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 9200, Lots 235991 and 238928. The letter provides the customers with an explanation of the problem identified and an action to be taken. The firm reminds customers that clinical consideration and professional judgment must be applied to any test result. Customers were instructed to retain the Product Notification letter for their records as documentation that they have received the information and to ensure that all users have a copy. Alere will replace the lots at the customer's request. As the customers complete the fax back form, they were instructed to indicate whether they wish to replace the affected product. Customers were instructed to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. If customers have any further questions or need to report any concerns they have about the Triage Drugs of Abuse Plus TCA performance, they were instructed to contact Technical Services at (877) 308-8287 or by e-mail at techservice@alere.com.
- Quantity
- 997 total kits
- Distribution
- Worldwide Distribution -- US and to Canada.
- Lot, serial or model codes
- Lots 235991 and 238928.
- 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
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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