Siemens Healthcare Diagnostics, Inc. recalls Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL
- Recalling company
- Siemens Healthcare Diagnostics, Inc.
- Product
- Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 13, 2026
- Reported
- Aug 26, 2026
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Status
- Ongoing
- Quantity
- 20 units
- Lot / codes
- Lot U1/UDI: 00842768001048
- Company location
- East Walpole, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2975-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2975-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.