Device recall
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- Recall number
- Z-2975-2026
- Event id
- 99446
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Report date
- Aug 26, 2026
- Posted
- Aug 17, 2026
- Initiated
- Jul 13, 2026
- Center classification date
- Aug 17, 2026
- Product code
- LBZ
- Device type
- Enzyme Immunoassay, Quinidine
- Reason
- 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.
- Root cause
- Unknown/Undetermined by firm
- Quantity
- 20 units
- Code info
- Lot U1/UDI: 00842768001048
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K922913
- Location
- East Walpole, MA, United States