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ARK™ HS Benzodiazepine II 150/250ng/mL Control

ARK DIAGNOSTICS INC · Model 5073-0003-01 · UDI-DI 00812101030554

LAS Prescription
10
510(k) clearances
2
Adverse events
1
Recalls
24
Facilities

Description

ARK™ HS Benzodiazepine II 150/250ng/mL Control is intended for use in quality control of the ARK™ HS Benzodiazepine II Assay.

Recalls

DateFirmReason
2013-10-03Lin-Zhi International IncProduct catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.

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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.