- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Affected products (lot / model / serial)
- Lots: 2597, 2627, 2709/UDI: 00842768023293
- Units affected
- 55 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Firm location
- East Walpole, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2976-2026
- Recall initiated
- July 13, 2026
- FDA classification date
- August 17, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99446
- Last updated on HTM Vibe
- September 8, 2026