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CLIAwaived

Cliawaived, Inc. · Model CLIA-RDDT-52 · UDI-DI 00816610020105

DJRDISJXMDKZLDJDJCDJGDIO Prescription
1
510(k) clearances
16
Adverse events
7
Recalls
81
Facilities

Description

Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100

Recalls

DateFirmReason
2017-11-28Alere San Diego Inc. DBA Immunalysis CorporationThe 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
2014-02-05Alere 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
2012-05-14Alere 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
2010-03-12Alere San Diego dba Biosite Innovacon Hemosense IncThe recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.
2009-05-28Alere San Diego, Inc.Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
2008-05-28Sun Biomedical Laboratories, Inc.Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
2008-05-28Sun 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.