FDAFDA recall Z-2975-2026 · Aug 26, 2026
Siemens Healthcare Diagnostics, Inc.: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL recall
Recall found
Product
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot U1/UDI: 00842768001048
- Quantity
- 20 units
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., East Walpole, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-13
Source: openFDA enforcement record Z-2975-2026 · search recall number Z-2975-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.