Class IIDeviceOngoing

Siemens Healthcare Diagnostics, Inc.

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

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.

Details

Recall number: Z-2975-2026
Event ID: 99446
Recall initiated: Jul 13, 2026
Classified: Aug 17, 2026
Reported: Aug 26, 2026
Quantity: 20 units
Distribution: Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: East Walpole, MA, United States
Lot / code info: Lot U1/UDI: 00842768001048