Siemens Syva EMIT 2000 Quinidine Assay recalled for inaccurate test results
What this means
Certain lots of the Siemens Syva EMIT 2000 Quinidine Assay produced inaccurate test results that may show falsely high quinidine levels in blood. This could lead doctors to make wrong treatment decisions, potentially causing serious heart rhythm problems or inadequate treatment for malaria.
- If your laboratory uses lot U1/UDI 00842768001048, stop using it immediately and contact Siemens Healthcare Diagnostics.
- Review recent quinidine test results from affected lots with your quality assurance team.
- Contact Siemens Healthcare Diagnostics for instructions on replacement or alternative testing.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2975-2026More Siemens recalls
- FDA-Device2026-08-26Beckman Coulter Emit 2000 Quinidine Assay recalled for inaccurate test results
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