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Pointe Methadone Metabolite (EDDP) Reagent Set

HORIBA INSTRUMENTS INCORPORATED · Model 60-MM0380-100 · UDI-DI 00811727018076

DJR Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Metabolite (EDDP) Reagent Set is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.

Recalls

Date	Firm	Reason
2017-11-28	Alere San Diego Inc. DBA Immunalysis Corporation	The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is belo
2014-02-05	Alere San Diego, Inc.	Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these
2012-05-14	Alere San Diego, Inc.	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 fre
2010-03-12	Alere San Diego dba Biosite Innovacon Hemosense Inc	The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.
2009-05-28	Alere San Diego, Inc.	Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
2008-05-28	Sun Biomedical Laboratories, Inc.	Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
2008-05-28	Sun Biomedical Laboratories, Inc.	Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.