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ARK™ Ketamine Assay
ARK DIAGNOSTICS INC · Model 5056-0001-00 · UDI-DI 00812101030004
DKZ
Prescription
10
510(k) clearances
62
Adverse events
24
Recalls
94
Facilities
Description
The ARK™ Ketamine Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of ketamines in human urine at a cutoff concentration of 50 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ketamines in urine on automated clinical chemistry analyzers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2020-08-18 | Ameditech Inc | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| 2020-08-18 | Ameditech Inc | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| 2020-08-18 | Ameditech Inc | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| 2017-11-14 | Alere San Diego, Inc. | The recalled lots have demonstrated unexpected false positive THC results. |
| 2014-09-23 | Ameditech Inc | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphi |
| 2014-09-23 | Ameditech Inc | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphi |
| 2014-09-23 | Ameditech Inc | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphi |
| 2013-07-29 | Sarken, Inc. | These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and i |
| 2013-07-29 | Sarken, Inc. | These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and i |
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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.