Emit 2000 Quinidine Assay, Model OSR4Q229

• • Ongoing Z-2976-2026 FDA Class II ·initiated 13 Jul 2026

  Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

510(k) Number

K011605 ↗

FDA Product Code

LBZ

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Syva Co., Dade Behring, Inc. →