FDAFDA · Food and drugs·Recall number Z-2975-2026
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Published August 26, 2026 · Recall initiated: July 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Lot
- Lot U1/UDI: 00842768001048
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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