Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determ

FDA device recall Z-0521-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Alere San Diego

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DKZ

Quantity affected

997 total kits

Distribution

Worldwide Distribution -- US and to Canada.

Date initiated

2011-07-01

Date posted

2012-01-11

Date terminated

2012-04-04

Location

San Diego, CA

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