TemporaryFDAOngoing
Can cause harm that is usually temporary.
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Check the device or its packaging for
Lot U1/UDI: 00842768001048
- Why
- 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.
- Distributed
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Company
- Siemens Healthcare Diagnostics, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2975-2026 · retrieved 17 August 2026
Read the official notice