FDA Device

Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the 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 antidepr

Hazard

A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.

What You Should Do

Remedy

Alere sent an Urgent Medical Device Recall letter dated June 11, 2012 to all affected customers. The letter informed the customers of the affected product, problem identified and actions to be taken. Customers were instructed to discontinue all use of the recalled lots, immediately inform clinicians of this recall at the testing site(s) and complete and fax the enclosed customer verification form and list of affected lots within 10 days to confirm receipt of the letter. Customers with questions about the information contained in the recall letter, can contact Alere San Diego at 9975 Summers Ridge Road, San Diego, CA 92121 or call (877) 308-8287.

Products

Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of t
Brand
Alere San Diego, Inc.
UPC
Lot/Unit Codes: W50216B, W50222B, W50245B, W50250B, W50809B, W50810B, W50812B, W50813B, W50816B, W50817B, W50818B, W50819B, W50820B, W50821B, W50822B, W50823B, W50826B, W50829B, W50830B, W50831B, W50832B, W50837B, W50838B, W50842B, W50843B, W50844B, W50846B, W50848B, W50851B, W50862B, W50866B, W50869B, W50870B, W50871B, W50872B, W50873B.

Units Affected

9,997 kits