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ARK™ EDDP Assay
ARK DIAGNOSTICS INC · Model 5051-0001-00 · UDI-DI 00858724003841
DJR
Prescription
1
510(k) clearances
16
Adverse events
7
Recalls
82
Facilities
Description
The ARK™ EDDP Assay is intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting EDDP in urine and is designated for professional 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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Get your free API keyRead the docsData 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.