FDA Medical devices recall ·
Syva EMIT 2000 Quinidine Assay recall
- Recall number
- Z-2975-2026
- Date
- (initiated July 13, 2026)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
333 Coney St, East Walpole, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot U1/UDI: 00842768001048
Distribution
Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
States: California
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2975-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.