Beckman Coulter Emit 2000 Quinidine Assay recalled for inaccurate test results
What this means
Certain lots of the Beckman Coulter Emit 2000 Quinidine Assay (a laboratory test kit) have precision problems that can cause falsely high quinidine readings. These inaccurate results may lead to incorrect patient treatment decisions, potentially causing serious heart rhythm problems or inadequate therapy.
- Check if your laboratory uses affected lots 2597, 2627, or 2709
- Contact Siemens Healthcare Diagnostics or your supplier for guidance on affected units
- Review recent quinidine test results from potentially affected lots and consider retesting if needed
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-2976-2026More Siemens recalls
- FDA-Device2026-08-26Siemens Syva EMIT 2000 Quinidine Assay recalled for inaccurate test results
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