Medical Device Recall: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Siemens Healthcare Diagnostics, Inc. · July 13, 2026
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
States Affected
NATIONWIDE
Quantity Affected
20 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2975-2026
Status: ongoing
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